Search results for: surgical excision
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 907

Search results for: surgical excision

667 Clinical Empathy: The Opportunity to Offer Optimal Treatment to People with Serious Illness

Authors: Leonore Robieux, Franck Zenasni, Marc Pocard, Clarisse Eveno

Abstract:

Empirical data in health psychology studies show the necessity to consider the doctor-patient communication and its positive impact on outcomes such as patients’ satisfaction, treatment adherence, physical and psychological wellbeing. In this line, the present research aims to define the role and determinants of an effective doctor–patient communication during the treatment of patients with serious illness (peritoneal carcinomatosis). We carried out a prospective longitudinal study including patients treated for peritoneal carcinomatosis of various origins. From November 2016, to date, data were collected using validated questionnaires at two times of evaluation: one month before the surgery (T0) and one month after (T1). Thus, patients reported their (a) anxiety and depression levels, (b) standardized and individualized quality of life and (c) how they perceived communication, attitude and empathy of the surgeon. 105 volunteer patients (Mean age = 58.18 years, SD = 10.24, 62.2% female) participated to the study. PC arose from rare diseases (14%), colorectal (38%), eso-gastric (24%) and ovarian (8%) cancer. Three groups are defined according to the severity of their pathology and the treatment offered to them: (1) important surgical treatment with the goal of healing (53%), (2) repeated palliative surgical treatment (17%), and (3) the patients recused for surgical treatment, only palliative approach (30%). Results are presented according to Baron and Kenny recommendations. The regressions analyses show that only depression and anxiety are sensitive to the communication and empathy of surgeon. The main results show that a good communication and high level of empathy at T0 and T1 limit depression and anxiety of the patients in T1. Results also indicate that the severity of the disease modulates this positive impact of communication: better is the communication the less are the level of depression and anxiety of the patients. This effect is higher for patients treated for the more severe disease. These results confirm that, even in the case severe disease a good communication between patient and physician remains a significant factor in promoting the well-being of patients. More specific training need to be developed to promote empathic care.

Keywords: clinical empathy, determinants, healthcare, psychological wellbeing

Procedia PDF Downloads 125
666 Nose Macroneedling Tie Suture Hidden Technique

Authors: Mohamed Ghoz, Hala Alsabeh

Abstract:

Context: Macroscopic Nose Macroneedling (MNM) is a new non-surgical procedure for lifting and tightening the nose. It is a tissue-non-invasive technique that uses a needle to create micro-injuries in the skin. These injuries stimulate the production of collagen and elastin, which results in the tightening and lifting of the skin. Research Aim: The research aim of this study was to investigate the efficacy and safety of MNM for the treatment of nasal deformities. Methodology A total of 100 patients with nasal deformities were included in this study. The patients were randomly assigned to either the MNM group or the control group. The MNM group received a single treatment of MNM, while the control group received no treatment. The patients were evaluated at baseline, 6 months, and 12 months after treatment. Findings: The results of this study showed that MNM was effective in improving the appearance of the nose in patients with nasal deformities. At 6 months after treatment, the patients in the MNM group had significantly improved nasal tip projection, nasal bridge height, and nasal width compared to the patients in the control group. The improvements in nasal appearance were maintained at 12 months after treatment. Theoretical Importance: The findings of this study provide support for the use of MNM as a safe and effective treatment for nasal deformities. MNM is a non-surgical procedure that is associated with minimal downtime and no risk of scarring. This makes it an attractive option for patients who are looking for a minimally invasive treatment for their nasal deformities. Data Collection: Data was collected from the patients using a variety of methods, including clinical assessments, photographic assessments, and patient-reported outcome measures. Analysis Procedures: The data was analyzed using a variety of statistical methods, including descriptive statistics, inferential statistics, and meta-analysis. Question Addressed: The research question addressed in this study was whether MNM is an effective and safe treatment for nasal deformities. Conclusion: The findings of this study suggest that MNM is an effective and safe treatment for nasal deformities. MNM is a non-surgical procedure that is associated with minimal downtime and no risk of scarring. This makes it an attractive option for patients who are looking for a minimally invasive treatment for their nasal deformities.

Keywords: nose, surgery, tie, suture

Procedia PDF Downloads 78
665 Outcome of Anastomosis of Mechanically Prepared vs Mechanically Unprepared Bowel in Laparoscopic Anterior Resection in Surgical Units of Teaching Hospital Karapitiya ,Sri Lanka

Authors: K. P. v. R. de Silva, R. W. Senevirathna, M. M. A. J. Kumara, J. P. M. Kumarasinghe, R. L. Gunawardana, S. M. Uluwitiya, G. C. P. Jayawickrama, W. K. T. I. Madushani

Abstract:

Introduction: The limited literature supporting the utilization of mechanical bowel preparation (MBP) for patients undergoing laparoscopic anterior resection (LAR) remains a notable issue. This study was conducted to examine the clinical consequences of anastomosis in colorectal surgery with MBP compared to cases where MBP was not utilized (no-MBP) in the context of LAR. Methods: This was a retrospective comparative study conducted in the professorial surgical wards of the teaching hospital karapitiya (THK). Colorectal cancer patients(n=306) participated in the study, including 151 MBP patients and 155 no-MBP patients, where the postoperative complications and mortality rates were compared. Results: The anastomotic leakage rate was 2.6%(n=4) in the no-MBP group and 6.0%(n=9) in the MBP group (p=0.143). The postoperative paralytic ileus rate was 18.5%(n=28) and 5.8%(n=9) in the MBP group and no-MBP group, respectively, displaying a statistically significant difference (p=0.001). Wound infection, pneumonia, urinary tract infection, and cardiac complication rates also were higher in the MBP group. The overall mortality rate was 1.3%(n=3) in the no-MBP group and 2.0%(n=2) in the MBP group. Conclusions: The evidence concludes that MBP increases post-operative complications. Therefore, prophylactic MBP in LAR has not been proven to benefit patients. However, further research is necessary to understand the comparative effects of MBP versus no preparation comprehensively.

Keywords: MBP, anastomosis, LAR, paralytic ileus

Procedia PDF Downloads 95
664 Umbilical Epidermal Inclusion Cysts, a Rare Cause of Umbilical Mass: A Case Report and Review of Literature

Authors: Christine Li, Amanda Robertson

Abstract:

Epidermal inclusion cysts occur when epidermal cells are implanted in the dermis following trauma, or surgery. They are a rare cause of an umbilical mass, with very few cases previously reported following abdominal surgery. These lesions can present with a range of symptoms, including palpable mass, pain, redness, or discharge. This paper reports a case of an umbilical epidermal inclusion cyst in a 52-year-old female presenting with a six-week history of a painful, red umbilical lump on a background of two previous diagnostic laparoscopies. Abdominal computed tomography (CT) scans revealed non-specific soft tissue thickening in the umbilical region. This was successfully treated with complete excision of the lesion. Umbilical lumps are a common presentation but can represent a diagnostic challenge. The differential diagnosis should include an epidermal inclusion cyst, particularly in a patient who has had previous abdominal surgery, including laparoscopic surgery.

Keywords: epidermal inclusion cyst, laparoscopy, umbilical mass, umbilicus

Procedia PDF Downloads 89
663 Apollo Quality Program: The Essential Framework for Implementing Patient Safety

Authors: Anupam Sibal

Abstract:

Apollo Quality Program(AQP) was launched across the Apollo Group of Hospitals to address the four patient safety areas; Safety during Clinical Handovers, Medication Safety, Surgical Safety and the six International Patient Safety Goals(IPSGs) of JCI. A measurable, online, quality dashboard covering 20 process and outcome parameters was devised for monthly monitoring. The expected outcomes were also defined and categorized into green, yellow and red ranges. An audit methodology was also devised to check the processes for the measurable dashboard. Documented clinical handovers were introduced for the first time at many locations for in-house patient transfer, nursing-handover, and physician-handover. Prototype forms using the SBAR format were made. Patient-identifiers, read-back for verbal orders, safety of high-alert medications, site marking and time-outs and falls risk-assessment were introduced for all hospitals irrespective of accreditation status. Measurement of Surgical-Site-Infection (SSI) for 30 days postoperatively, was done. All hospitals now tracked the time of administration of antimicrobial prophylaxis before surgery. Situations with high risk of retention of foreign body were delineated and precautionary measures instituted. Audit of medications prescribed in the discharge summaries was made uniform. Formularies, prescription-audits and other means for reduction of medication errors were implemented. There is a marked increase in the compliance to processes and patient safety outcomes. Compliance to read-back for verbal orders rose from 86.83% in April’11 to 96.95% in June’15, to policy for high alert medications from 87.83% to 98.82%, to use of measures to prevent wrong-site, wrong-patient, wrong procedure surgery from 85.75% to 97.66%, to hand-washing from 69.18% to 92.54%, to antimicrobial prophylaxis within one hour before incision from 79.43% to 93.46%. Percentage of patients excluded from SSI calculation due to lack of follow-up for the requisite time frame decreased from 21.25% to 10.25%. The average AQP scores for all Apollo Hospitals improved from 62 in April’11 to 87.7 in Jun’15.

Keywords: clinical handovers, international patient safety goals, medication safety, surgical safety

Procedia PDF Downloads 262
662 Efficacy of Hemi-Facetectomy in Treatment of Lumbar Foraminal Stenosis

Authors: Manoj Deepak, N. Mathivanan, K. Venkatachalam

Abstract:

Nerve root stenosis is one of the main cause for back pain. There are many methods both conservative and surgical to treat this disease. It is pertinent to decompress the spine to a proper extent so as to avoid the recurrence of symptoms. But too much of an aggressive approach also has its disadvantages. We present one of the methods to effectively decompress the nerve with better results. Our study was carried out in 52 patients with foramina stenosis between 2008 to 2011.We carried out the surgical procedure of shaving off the medial part of the facet joint so as to decompress the root. We selected those patients who had symptoms of claudication for more than 2 years. They had no signs of instability and they underwent conservative treatment for a period of 2 months before the procedure. Oswersty scoring was used to record the functional level of the patient before and after the procedure. All patients were followed up for a period of minimum 2.5 years. After evaluation for a minimum of 2.5 years, 34 patients had no evidence of recurrence of symptoms with improvement in the functional level.7 patients complained of minimal pain but their functional quality had improved postop. Six patients had symptoms of lumbar canal disease which reduced with conservative treatment. 5 patients required spinal fusion surgeries in the later period. Conclusion: Thus, we can effectively conclude that our procedure is safe and effective in reducing the symptoms in those patients with neurogenic claudication.

Keywords: facetectoemy, stenosis, decompression, Lumbar Foraminal Stenosis, hemi-facetectomy

Procedia PDF Downloads 351
661 Antibiotic Prescribing in the Acute Care in Iraq

Authors: Ola A. Nassr, Ali M. Abd Alridha, Rua A. Naser, Rasha S. Abbas

Abstract:

Background: Excessive and inappropriate use of antimicrobial agents among hospitalized patients remains an important patient safety and public health issue worldwide. Not only does this behavior incur unnecessary cost but it is also associated with increased morbidity and mortality. The objective of this study is to obtain an insight into the prescribing patterns of antibiotics in surgical and medical wards, to help identify a scope for improvement in service delivery. Method: A simple point prevalence survey included a convenience sample of 200 patients admitted to medical and surgical wards in a government teaching hospital in Baghdad between October 2017 and April 2018. Data were collected by a trained pharmacy intern using a standardized form. Patient’s demographics and details of the prescribed antibiotics, including dose, frequency of dosing and route of administration, were reported. Patients were included if they had been admitted at least 24 hours before the survey. Patients under 18 years of age, having a diagnosis of cancer or shock, or being admitted to the intensive care unit, were excluded. Data were checked and entered by the authors into Excel and were subjected to frequency analysis, which was carried out on anonymized data to protect patient confidentiality. Results: Overall, 88.5% of patients (n=177) received 293 antibiotics during their hospital admission, with a small variation between wards (80%-97%). The average number of antibiotics prescribed per patient was 1.65, ranging from 1.3 for medical patients to 1.95 for surgical patients. Parenteral third-generation cephalosporins were the most commonly prescribed at a rate of 54.3% (n=159) followed by nitroimidazole 29.4% (n=86), quinolones 7.5% (n=22) and macrolides 4.4% (n=13), while carbapenems and aminoglycosides were the least prescribed together accounting for only 4.4% (n=13). The intravenous route was the most common route of administration, used for 96.6% of patients (n=171). Indications were reported in only 63.8% of cases. Culture to identify pathogenic organisms was employed in only 0.5% of cases. Conclusion: Broad-spectrum antibiotics are prescribed at an alarming rate. This practice may provoke antibiotic resistance and adversely affect the patient outcome. Implementation of an antibiotic stewardship program is warranted to enhance the efficacy, safety and cost-effectiveness of antimicrobial agents.

Keywords: Acute care, Antibiotic misuse, Iraq, Prescribing

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660 A Comparative Study on the Dimensional Error of 3D CAD Model and SLS RP Model for Reconstruction of Cranial Defect

Authors: L. Siva Rama Krishna, Sriram Venkatesh, M. Sastish Kumar, M. Uma Maheswara Chary

Abstract:

Rapid Prototyping (RP) is a technology that produces models and prototype parts from 3D CAD model data, CT/MRI scan data, and model data created from 3D object digitizing systems. There are several RP process like Stereolithography (SLA), Solid Ground Curing (SGC), Selective Laser Sintering (SLS), Fused Deposition Modelling (FDM), 3D Printing (3DP) among them SLS and FDM RP processes are used to fabricate pattern of custom cranial implant. RP technology is useful in engineering and biomedical application. This is helpful in engineering for product design, tooling and manufacture etc. RP biomedical applications are design and development of medical devices, instruments, prosthetics and implantation; it is also helpful in planning complex surgical operation. The traditional approach limits the full appreciation of various bony structure movements and therefore the custom implants produced are difficult to measure the anatomy of parts and analyse the changes in facial appearances accurately. Cranioplasty surgery is a surgical correction of a defect in cranial bone by implanting a metal or plastic replacement to restore the missing part. This paper aims to do a comparative study on the dimensional error of CAD and SLS RP Models for reconstruction of cranial defect by comparing the virtual CAD with the physical RP model of a cranial defect.

Keywords: rapid prototyping, selective laser sintering, cranial defect, dimensional error

Procedia PDF Downloads 327
659 Effect of Scaling and Root Planing on Improvement of Glycemic Control in Periodontitis Patients with Type-2 Diabetes Mellitus

Authors: Shivalal Sharma, Sanjib K. Sharma, Madhab Lamsal

Abstract:

Background: The aim of this study was to evaluate the clinical and laboratory changes three months after full-mouth scaling and root planing (SRP) in periodontitis patients with type 2 diabetes mellitus (DM). Methods: Forty-seven type 2 DM subjects with moderate to severe periodontitis were randomly divided into two groups. Treatment group (TG), 25 subjects, received full-mouth scaling and root planning; control group (CG), 22 subjects, received no treatment. At baseline and at the end of three months, glycated hemoglobin (HbA1c) values, fasting glucose, and clinical parameters like plaque index (PI), gingival index (GI), probing pocket depth (PPD), and clinical attachment level (CAL) were recorded in all the patients. Following SRP, the patients were enrolled in a monthly interval maintenance program for 3 months. Results: A statistically significant effect could be demonstrated for PI, GI, PPD, and CAL for the treatment group. HbA1c levels in the treatment group decreased significantly whereas the control group showed a slight but insignificant increase for these parameters. Conclusions: The results of this study showed that non-surgical periodontal treatment (SRP) is associated with improved glycemic control in type 2 DM patients and could be undertaken along with the standard measures for the diabetic patient care.

Keywords: periodontitis, type 2 diabetes mellitus, non-surgical periodontal therapy, SRP

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658 The Incidence of Inferior Alveolar Nerve Dysfunction Following Bilateral Sagittal Split Osteotomies: A Single Centre Retrospective Audit in the United Kingdom

Authors: Krupali Mukeshkumar, Jinesh Shah

Abstract:

Background: Bilateral Sagittal Split Osteotomy (BSSO), used for the correction of mandibular deformities, is a common oral and maxillofacial surgical procedure. Inferior alveolar nerve dysfunction is commonly reported post-operatively by patients as paresthesia or anesthesia. The current literature lacks a consensus on the incidence of inferior alveolar nerve dysfunction as patients are not routinely assessed pre and post-operatively with an objective assessment. The range of incidence varies from 9% to 85% of patients, with some authors arguing that 100% of patients experience nerve dysfunction immediately post-surgery. Systematic reviews have shown a difference between incidence rates at different follow-up periods using objective and subjective methods. Aim: To identify the incidence of inferior alveolar nerve dysfunction following BSSO. Gold standard: Nerve dysfunction incidence rates similar or lower than current literature of 83% day one post-operatively and 18.4% at one year follow up. Setting: A retrospective cross-sectional audit of patients treated between 2017-2019 at the Royal Stoke University Hospital, Maxillofacial and Orthodontic departments. Sample: All patients who underwent a BSSO (with or without le fort one osteotomy) between 2017–2019 were identified from the database. Patients with pre-existing neurosensory disturbance, those who had a genioplasty at the same time and those with no follow-up were excluded. The sample consisted of 121 patients, 37 males and 84 females between the ages of 17-50 years at the time of surgery. Methods: Clinical records of 121 cases were reviewed to assess the age, sex, type of mandibular osteotomy, status of the nerve during the surgical procedure, type of bony split and incidence of nerve dysfunction at follow-up appointments. The surgical procedure was carried out by three Maxillo-facial surgeons and follow-up appointments were carried out in the Orthodontic and Oral and Maxillo-facial departments. Results: 120 patients were treated to correct the mandibular facial deformity and 1 patient was treated for sleep apnoea. Seventeen patients had a mandibular setback and 104 patients had mandibular advancement. 68 patients reported inferior alveolar nerve dysfunction at one week following their surgery. Seventy-six patients had temporary paresthesia present between 2 weeks and 12 months post-surgery. 13 patients had persistent nerve dysfunction at 12 months, of which 1 had a bad bony split during the BSSO. The incidence of nerve dysfunction postoperatively was 6.6% after 1 day, 56.1% at 1 week, 62.8% at 2 weeks, 59.5% between 3-6 weeks, 43.0% between 8-16 weeks and 10.7% at 1 year. Conclusions: The results of this audit show a similar incidence rate to the research gold standard at the one-year follow-up. Future Recommendations: No changes to surgical procedure or technique are indicated, but a need for improved documentation and a standardized approach for assessment of post-operative nerve dysfunction would be beneficial.

Keywords: bilateral sagittal split osteotomy, inferior alveolar nerve, mandible, nerve dysfunction

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657 The Nursing Experience in a Stroke Patient after Lumbar Surgery at Surgical Intensive Care Unit

Authors: Yu-Chieh Chen, Kuei-Feng Shen, Chia-Ling Chao

Abstract:

The purpose of this report was to present the nursing experience and case of an unexpected cerebellar hemorrhagic stroke with acute hydrocephalus patient after lumbar spine surgery. The patient had been suffering from an emergent external ventricular drainage and stayed in the Surgical Intensive Care Unit from July 8, 2016, to July 22, 2016. During the period of the case, the data were collected for attendance, evaluation, observation, interview, searching medical record, etc. An integral evaluation of the patient's physiological 'psychological' social and spiritual states was also noted. The author noticed the following major nursing problems including ineffective cerebral perfusion 'physical activity dysfunction' family resource preparation for disability. The author provided nursing care to maintain normal intracranial pressure, along with a well-therapeutic relationship and applied interdisciplinary medical/nursing team to draft an individualized and appropriate nursing plan for them to face the psychosocial impact of the patient disabilities. We also actively participated in the rehabilitation treatments to improve daily activity and confidence. This was deemed necessary to empower them to a more positive attitude in the future.

Keywords: family resourace preparation inability, hemorrhagic sroke, ineffective tissue cerebral perfusion, lumbar spine surgery

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656 Oncogenic Role of MicroRNA-346 in Human Non-Small Cell Lung Cancer by Regulation of XPC/ERK/Snail/E-Cadherin Pathway

Authors: Cheng-Cao Sun, Shu-Jun Li, De-Jia Li

Abstract:

Determinants of growth and metastasis in cancer remain of great interest to define. MicroRNAs (miRNAs) have frequently emerged as tumor metastatic regulator by acting on multiple signaling pathways. Here, we report the definition of miR-346 as an oncogenic microRNA that facilitates non-small cell lung cancer (NSCLC) cell growth and metastasis. XPC, an important DNA damage recognition factor in nucleotide excision repair was defined as a target for down-regulation by miR-346, functioning through direct interaction with the 3'-UTR of XPC mRNA. Blocking miR-346 by an antagomiR was sufficient to inhibit NSCLC cell growth and metastasis, an effect that could be phenol-copied by RNAi-mediated silencing of XPC. In vivo studies established that miR-346 overexpression was sufficient to promote tumor growth by A549 cells in xenografts mice, relative to control cells. Overall, our results defined miR-346 as an oncogenic miRNA in NSCLC, the levels of which contributed to tumor growth and invasive aggressiveness.

Keywords: microRNA-346, miR-346, XPC, non-small cell lung cancer, oncogenesis

Procedia PDF Downloads 315
655 Pre-Operative Tool for Facial-Post-Surgical Estimation and Detection

Authors: Ayat E. Ali, Christeen R. Aziz, Merna A. Helmy, Mohammed M. Malek, Sherif H. El-Gohary

Abstract:

Goal: Purpose of the project was to make a plastic surgery prediction by using pre-operative images for the plastic surgeries’ patients and to show this prediction on a screen to compare between the current case and the appearance after the surgery. Methods: To this aim, we implemented a software which used data from the internet for facial skin diseases, skin burns, pre-and post-images for plastic surgeries then the post- surgical prediction is done by using K-nearest neighbor (KNN). So we designed and fabricated a smart mirror divided into two parts a screen and a reflective mirror so patient's pre- and post-appearance will be showed at the same time. Results: We worked on some skin diseases like vitiligo, skin burns and wrinkles. We classified the three degrees of burns using KNN classifier with accuracy 60%. We also succeeded in segmenting the area of vitiligo. Our future work will include working on more skin diseases, classify them and give a prediction for the look after the surgery. Also we will go deeper into facial deformities and plastic surgeries like nose reshaping and face slim down. Conclusion: Our project will give a prediction relates strongly to the real look after surgery and decrease different diagnoses among doctors. Significance: The mirror may have broad societal appeal as it will make the distance between patient's satisfaction and the medical standards smaller.

Keywords: k-nearest neighbor (knn), face detection, vitiligo, bone deformity

Procedia PDF Downloads 171
654 Wrong Site Surgery Should Not Occur In This Day And Age!

Authors: C. Kuoh, C. Lucas, T. Lopes, I. Mechie, J. Yoong, W. Yoong

Abstract:

For all surgeons, there is one preventable but still highly occurring complication – wrong site surgeries. They can have potentially catastrophic, irreversible, or even fatal consequences on patients. With the exponential development of microsurgery and the use of advanced technological tools, the consequences of operating on the wrong side, anatomical part, or even person is seen as the most visible and destructive of all surgical errors and perhaps the error that is dreaded by most clinicians as it threatens their licenses and arouses feelings of guilt. Despite the implementation of the WHO surgical safety checklist more than a decade ago, the incidence of wrong-site surgeries remains relatively high, leading to tremendous physical and psychological repercussions for the clinicians involved, as well as a financial burden for the healthcare institution. In this presentation, the authors explore various factors which can lead to wrong site surgery – a combination of environmental and human factors and evaluate their impact amongst patients, practitioners, their families, and the medical industry. Major contributing factors to these “never events” include deviations from checklists, excessive workload, and poor communication. Two real-life cases are discussed, and systems that can be implemented to prevent these errors are highlighted alongside lessons learnt from other industries. The authors suggest that reinforcing speaking-up, implementing medical professional trainings, and higher patient’s involvements can potentially improve safety in surgeries and electrosurgeries.

Keywords: wrong side surgery, never events, checklist, workload, communication

Procedia PDF Downloads 186
653 Osteitis in the Diabetic Foot in Algeria

Authors: Mohamed Amine Adaour, Mohamed Sadek Bachene, Mosaab Fortassi, Wafaa Siouda

Abstract:

— Foot infections are responsible for a significant number of hospitalizations and amputations in diabetic patients. The objective of our study is to analyze and evaluate the management of diabetic foot in a surgical setting. A retrospective study was conducted based on a selected case of suspected diabetic foot infections of osteitis treated at the Mohamed Boudiaf hospital in Medea.The case was reiterated as a therapeutic charge, consisting of treating first the infection of the soft tissues, then the osteitis: biopsy after at least 15 days of cessation of antibiotic therapy. Successful treatment of osteitis was defined at the end of a follow-up period of complete wound healing, lack of bone resection/amputation surgery at the initial bone site during follow-up , Instead, biopsies are prescribed in the treatment of soft tissue infection. The mean duration of treatment for soft tissue infection was 2-3 weeks, the duration of the antibiotic-free window of therapy prior to bone biopsy was 2-4 weeks. This patient received medical management without surgical resection. The success rate for treating osteitis at one year was 73%, and healing at one year was 88%.It is often limited to a sausage of the foot at the cost of repeated amputations. The best management remains prevention, which necessarily involves setting up a specialized and adapted centre.

Keywords: diabetic foot, bone biopsy, osteitis, algeria

Procedia PDF Downloads 108
652 Physiopathology of Osteitis in the Diabetic Foot

Authors: Mohamed Amine Adaour, Mohamed Sadek Bachene, Mosaab Fortassi, Wafaa Siouda

Abstract:

Foot infections are responsible for a significant number of hospitalizations and amputations in diabetic patients. The objective of our study is to analyze and evaluate the management of diabetic foot in a surgical setting. A retrospective study was conducted based on a selected case of suspected diabetic foot infections of osteitis treated at the Mohamed Boudiaf hospital in Medea. The case was reiterated as a therapeutic charge, consisting of treating first the infection of the soft tissues, then the osteitis: biopsy after at least 15 days of cessation of antibiotic therapy. Successful treatment of osteitis was defined at the end of a follow-up period of complete wound healing, lack of bone resection/amputation surgery at the initial bone site during follow-up , Instead, biopsies are prescribed in the treatment of soft tissue infection. The mean duration of treatment for soft tissue infection was 2-3 weeks, the duration of the antibiotic-free window of therapy prior to bone biopsy was 2-4 weeks. This patient received medical management without surgical resection. The success rate for treating osteitis at one year was 73%, and healing at one year was 88%.It is often limited to a sausage of the foot at the cost of repeated amputations. The best management remains prevention, which necessarily involves setting up a specialized and adapted centre.

Keywords: osteitis, antibiotic therapy, bone biopsy, diabetic foot

Procedia PDF Downloads 84
651 Osteitis in the Diabetic Foot and the Risk Factor on the Population

Authors: Mohamed Amine Adaour, Mohamed Sadek Bachene, Mosaab Fortassi, Wafaa Siouda

Abstract:

Foot infections are responsible for a significant number of hospitalizations and amputations in diabetic patients. The objective of our study is to analyze and evaluate the management of diabetic foot in a surgical setting. A retrospective study was conducted based on a selected case of suspected diabetic foot infections of osteitis treated at the Mohamed Boudiaf hospital in Medea.The case was reiterated as a therapeutic charge, consisting of treating first the infection of the soft tissues, then the osteitis: biopsy after at least 15 days of cessation of antibiotic therapy. Successful treatment of osteitis was defined at the end of a follow-up period of complete wound healing, lack of bone resection/amputation surgery at the initial bone site during follow-up , Instead, biopsies are prescribed in the treatment of soft tissue infection. The mean duration of treatment for soft tissue infection was 2-3 weeks, the duration of the antibiotic-free window of therapy prior to bone biopsy was 2-4 weeks. This patient received medical management without surgical resection. The success rate for treating osteitis at one year was 73%, and healing at one year was 88%.It is often limited to a sausage of the foot at the cost of repeated amputations. The best management remains prevention, which necessarily involves setting up a specialized and adapted centre.

Keywords: osteitis, antibiotic, biopsy, diabetic foot

Procedia PDF Downloads 101
650 Salter Pelvic Osteotomy for the Treatment of Developmental Dysplasia of the Hip: Assessment of Postoperative Results and Risk Factors

Authors: Suvorov Vasyl, Filipchuk Viktor

Abstract:

Background: If non-surgical treatment of developmental dysplasia of the hip (DDH) fails or if DDH is late-detected, surgery is necessary. Salter pelvic osteotomy (SPO) is an effective surgical option for such cases. The objectives of this study were to assess the results after SPO, evaluate risk factors, and reveal those radiological parameters that may correlate with the results. Mid- and long-term postoperative results after SPO in 17 patients (22 hip joints) were analyzed. Risk factors included those that do not depend on the surgeon (patient's age, value of the acetabular index (AI) preoperatively, DDH Tonnis grade) and those that depend on the surgeon (amount of AI correction). To radiological parameters which may correlate with the amount of AI correction, we referred distance "d" and the lateral rotation angle. Results: SPO allows performing AI correction in ranges 24.1 ± 6.5°. Excellent and good clinical results were obtained in 95.5% of patients; excellent and good radiological results in 86.4% of patients. Risk factors that do not depend on the surgeon were older patient’s age and higher preoperative AI values (p < 0.05). The risk factor that depends on the surgeon was the amount of AI correction (p < 0.05). The distance "d" was recognized as a radiological parameter that may indicate sufficient AI correction (p < 0.05). Conclusion: In older patients with a higher preoperative AI value, the results will be predictably worse. The surgeon may influence the result with a greater amount of AI correction (which may also be indicated radiologically by the distance "d" values).

Keywords: developmental dysplasia of the hip, results, risk factor, pelvic osteotomy, salter osteotomy

Procedia PDF Downloads 134
649 Diagnostic Physiopathology of Osteitis in the Diabetic Foot

Authors: Adaour Mohamed Amine, Bachene Mohamed Sadek, Fortassi Mosaab, Siouda Wafaa

Abstract:

Foot infections are responsible for a significant number of hospitalizations and amputations in diabetic patients. The objective of our study is to analyze and evaluate the management of diabetic foot in a surgical setting. A retrospective study was conducted based on a selected case of suspected diabetic foot infections of osteitis treated at the Mohamed Boudiaf hospital in Medea. The case was reiterated as a therapeutic charge, consisting of treating first the infection of the soft tissues, then the osteitis: biopsy after at least 15 days of cessation of antibiotic therapy. Successful treatment of osteitis was defined at the end of a follow-up period of complete wound healing, lack of bone resection/amputation surgery at the initial bone site during follow-up , Instead, biopsies are prescribed in the treatment of soft tissue infection. The mean duration of treatment for soft tissue infection was 2-3 weeks, the duration of the antibiotic-free window of therapy prior to bone biopsy was 2-4 weeks. This patient received medical management without surgical resection. The success rate for treating osteitis at one year was 73% and healing at one year was 88%.It is often limited to a sausage of the foot at the cost of repeated amputations. The best management remains prevention, which necessarily involves setting up a specialized and adapted centre.

Keywords: osteitis, antibiotic therapy, bone biopsy, diabetic foot

Procedia PDF Downloads 106
648 Bionaut™: A Minimally Invasive Microsurgical Platform to Treat Non-Communicating Hydrocephalus in Dandy-Walker Malformation

Authors: Suehyun Cho, Darrell Harrington, Florent Cros, Olin Palmer, John Caputo, Michael Kardosh, Eran Oren, William Loudon, Alex Kiselyov, Michael Shpigelmacher

Abstract:

The Dandy-Walker malformation (DWM) represents a clinical syndrome manifesting as a combination of posterior fossa cyst, hypoplasia of the cerebellar vermis, and obstructive hydrocephalus. Anatomic hallmarks include hypoplasia of the cerebellar vermis, enlargement of the posterior fossa, and cystic dilatation of the fourth ventricle. Current treatments of DWM, including shunting of the cerebral spinal fluid ventricular system and endoscopic third ventriculostomy (ETV), are frequently clinically insufficient, require additional surgical interventions, and carry risks of infections and neurological deficits. Bionaut Labs develops an alternative way to treat Dandy-Walker Malformation (DWM) associated with non-communicating hydrocephalus. We utilize our discreet microsurgical Bionaut™ particles that are controlled externally and remotely to perform safe, accurate, effective fenestration of the Dandy-Walker cyst, specifically in the posterior fossa of the brain, to directly normalize intracranial pressure. Bionaut™ allows for complex non-linear trajectories not feasible by any conventional surgical techniques. The microsurgical particle safely reaches targets in the lower occipital section of the brain. Bionaut™ offers a minimally invasive surgical alternative to highly involved posterior craniotomy or shunts via direct fenestration of the fourth ventricular cyst at the locus defined by the individual anatomy. Our approach offers significant advantages over the current standards of care in patients exhibiting anatomical challenge(s) as a manifestation of DWM, and therefore, is intended to replace conventional therapeutic strategies. Current progress, including platform optimization, Bionaut™ control, and real-time imaging and in vivo safety studies of the Bionauts™ in large animals, specifically the spine and the brain of ovine models, will be discussed.

Keywords: Bionaut™, cerebral spinal fluid, CSF, cyst, Dandy-Walker, fenestration, hydrocephalus, micro-robot

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647 Papillary Thyroid Carcinoma Presenting as a Vascular Left Carotid Sheath Mass: A Case Report

Authors: Karthikeyan M., Paul M. J.

Abstract:

This case report discusses a 54-year-old woman from Salem, Tamilnadu, who presented with a rare case of papillary thyroid carcinoma (PTC), manifesting as a hypervascular mass in the left carotid sheath. The patient had a two-and-a-half-month history of non-progressive neck swelling, with symptoms including dysphagia and a choking sensation. Clinical examination and investigations such as FNAC and CECT revealed a large vascular mass in the left neck region, initially perplexing the diagnosis. The patient underwent total thyroidectomy and excision of the left carotid sheath mass. Histopathology confirmed PTC. Postoperatively, the patient received Iodine-131 ablation and showed good recovery with no recurrence. This case highlights the diagnostic challenge and atypical presentation of PTC as a vascular neck mass, emphasizing the importance of a comprehensive approach in evaluating thyroid and neck lesions.

Keywords: lateral neck vascular mass, lateral aberrant thyroid, thyroid vascular swelling, smooth post op recovery

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646 Glioblastoma: Prognostic Value of Clinical, Histopathological and Immunohistochemical (p53, EGFR, VEGF, MDM2, Ki67) Parameters

Authors: Sujata Chaturvedi, Ishita Pant, Deepak Kumar Jha, Vinod Kumar Singh Gautam, Chandra Bhushan Tripathi

Abstract:

Objective: To describe clinical, histopathological and immunohistochemical profile of glioblastoma in patients and to correlate these findings with patient survival. Material and methods: 30 cases of histopathologically diagnosed glioblastomas were included in this study. These cases were analysed in detail for certain clinical and histopathological parameters. Immunohistochemical staining for p53, epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), mouse double minute 2 homolog (MDM2) and Ki67 was done and scores were calculated. Results of these findings were correlated with patient survival. Results: A retrospective analysis of the histopathology records and clinical case files was done in 30 cases of glioblastoma (WHO grade IV). The mean age of presentation was 50.6 years with a male predilection. The most common involved site was the frontal lobe. Amongst the clinical parameters, age of the patient and extent of surgical resection showed a significant correlation with the patient survival. Histopathological parameters showed no significant correlation with the patient survival, while amongst the immunohistochemical parameters expression of MDM2 showed a significant correlation with the patient survival. Conclusion: In this study incorporating clinical, histopathological and basic panel of immunohistochemistry, age of the patient, extent of the surgical resection and expression of MDM2 showed significant correlation with the patient survival.

Keywords: glioblastoma, p53, EGFR, VEGF, MDM2, Ki67

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645 Sustainable Model of Outreach Eye Camps: A Case Study from Reputed Eye Hospital of Central India

Authors: Subramanyam Devarakonda Hanumantharao, Udayendu Prakash Sharma, Mahesh Garg

Abstract:

Introduction: Gomabai Netralaya a reputed eye hospital is located in Neemuch a small city of Madhya Pradesh, India. The hospital is established in 1992 by Late. G.D Agrawal a renowned educationist, freedom fighter and philanthropist. The eye hospital was established to serve all sections of the society in affordable manner. To provide comprehensive eye care services to the rural poor the hospital started organizing outreach camps since 1994. Purpose: To study the cost effectiveness of outreach eye camps for addressing the sustainability issues of the outreach program. Methods: One year statistics of outreach eye camps were collected from Hospital Management Information System software to analyze the productivity of camps. Income and expenses report was collected from outreach department records to analyze per camp expenses and per patient expenses against the income generated. All current year records were analyzed to have accuracy of information and results. Information was collected in two ways: 1)Actual camp performance records and expenses from book of accounts. 2)Cross verification was done through one to one discussion with outreach staff. Results: Total 17534 outpatients were examined through 52 outreach eye camps. Total 6042 (34% of total outpatients) patients were advised with cataracts and 4651 (77% of advice) operations were performed. The average OPD per camp was 337 and per camp 116 patients was advised for cataract surgery and 89 surgeries were performed per camp. Total 18200 US$ incurred on organizing 52 outreach camps in the radius of 100 k.ms. Considering the total outpatients screened through camps the screening cost per patient was 1.00 US$ and considering the surgical output the per surgery expenses was 4.00 US$. The cost recovery of the total expenses was through Government grant of US$ 16.00 per surgery (that includes surgical grant). All logistics cost of camps and patients transportation cost was taken care by local donors. Conclusion: The present study demonstrates that with people’s participation, successful high volume outreach eye camps can be organized. The cost effectiveness of the outreach camps is totally depended on volume of outpatient’s turn-up at camp site and per camp surgical output. The only solution to sustainability of outreach eye camps is sharing of cost with local donors and increasing productivity.

Keywords: camps, outreach, productivity, sustainable

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644 Efficacy of Erector Spinae Plane Block for Postoperative Pain Management in Coronary Artery Bypass Graft Patients

Authors: Santosh Sharma Parajuli, Diwas Manandhar

Abstract:

Background: Perioperative pain management plays an integral part in patients undergoing cardiac surgery. We studied the effect of Erector Spinae Plane block on acute postoperative pain reduction and 24 hours opioid consumption in adult cardiac surgical patients. Methods: Twenty-five adult cardiac surgical patients who underwent cardiac surgery with sternotomy in whom ESP catheters were placed preoperatively were kept in group E, and the other 25 patients who had undergone cardiac surgery without ESP catheter and pain management done with conventional opioid injection were placed in group C. Fentanyl was used for pain management. The primary study endpoint was to compare the consumption of fentanyl and to assess the numeric rating scale in the postoperative period in the first 24 hours in both groups. Results: The 24 hours fentanyl consumption was 43.00±51.29 micrograms in the Erector Spinae Plane catheter group and 147.00±60.94 micrograms in the control group postoperatively which was statistically significant (p <0.001). The numeric rating scale was also significantly reduced in the Erector Spinae Plane group compared to the control group in the first 24 hours postoperatively. Conclusion: Erector Spinae Plane block is superior to the conventional opioid injection method for postoperative pain management in CABG patients. Erector Spinae Plane block not only decreases the overall opioid consumption but also the NRS score in these patients.

Keywords: erector, spinae, plane, numerical rating scale

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643 Risk Factors for Postoperative Fever in Patients Undergoing Lumbar Fusion

Authors: Bang Haeyong

Abstract:

Purpose: The objectives of this study were to determine the prevalence, incidence, and risk factors for postoperative fever after lumbar fusion. Methods: This study was a retrospective chart review of 291 patients who underwent lumbar fusion between March 2015 and February 2016 at the Asan Medical Center. Information was extracted from electronic medical records. Postoperative fever was measured at Tmax > 37.7 ℃ and Tmax > 38.3 ℃. The presence of postoperative fever, blood culture, urinary excretion, and/or chest x-ray were evaluated. Patients were evaluated for infection after lumbar fusion. Results: We found 222 patients (76.3%) had a postoperative temperature of 37.7 ℃, and 162 patients (55.7%) had a postoperative temperature of 38.3 ℃ or higher. The percentage of febrile patients trended down following the mean 1.8days (from the first postoperative day to seventh postoperative day). Infection rate was 9 patients (3.1%), respiratory virus (1.7%), urinary tract infection (0.3%), phlebitis (0.3%), and surgical site infection (1.4%). There was no correlation between Tmax > 37.7℃ or Tmax > 38.3℃, and timing of fever, positive blood or urine cultures, pneumonia, or surgical site infection. Risk factors for increased postoperative fever following surgery were confirmed to be delay of defecation (OR=1.37, p=.046), and shorten of remove drainage (OR=0.66, p=.037). Conclusions: The incidence of fever was 76.3% after lumbar fusion and the drainage time was faster in the case of fever. It was thought that the bleeding was absorbed at the operation site and fever occurred. The prevalence of febrile septicemia was higher in patients with long bowel movements before surgery than after surgery. Clinical symptoms should be considered because postoperative fever cannot be determined by fever alone because fever and infection are not significant.

Keywords: lumbar surgery, fever, postoperative, risk factor

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642 Idiopathic Gingival Fibromatosis

Authors: Bandana Koirala, Shivalal Sharma

Abstract:

Introduction: Gingival enlargements are quite common and may be either inflammatory, non-inflammatory or a combination of both. Idiopathic gingival enlargement is a rare condition with a proliferative fibrous lesion of the gingival tissue that causes esthetic and functional problems. It is of undetermined etiology. Case Description: This case report addresses the diagnosis and treatment of a case of idiopathic gingival enlargement in a 9-year-old male patient. The patient presented with a generalized diffuse gingival enlargement involving the entire maxillary and the mandibular arch with extension on occlusal, buccal, lingual, and palatal surfaces with just parts of occlusal surfaces of few upper and lower molars visible resulting in open mouth, difficulty in mastication and speech. Biopsy report confirmed the diagnosis of fibromatosis gingivae. Gingivectomy was carried out in all four quadrants by using external bevel incision. Conclusion: Though total esthetics could not be restored due to unusual bony enlargement, the general appearance improved satisfactorily. Treatment after complete excision however, improved the masticatory competence to a great extent.

Keywords: idiopathic gingival fibromatosis, gingival enlargement, gingivectomy, medical and health sciences

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641 Application of Pedicled Perforator Flaps in Large Cavities of the Breast

Authors: Neerja Gupta

Abstract:

Objective-Reconstruction of large cavities of the breast without contralateral symmetrisation Background- Reconstruction of breast includes a wide spectrum of procedures from displacement to regional and distant flaps. The pedicled Perforator flaps cover a wide spectrum of reconstruction surgery for all quadrants of the breast, especially in patients with comorbidities. These axial flaps singly or adjunct are based on a near constant perforator vessel, a ratio of 2:1 at its entry in a flap is good to maintain vascularity. The perforators of lateral chest wall viz LICAP, LTAP have overlapping perfurosomes without clear demarcation. LTAP is localized in the narrow zone between the lateral breast fold and anterior axillary line,2.5-3.8cm from the fold. MICAP are localized at 1-2 cm from sternum. Being 1-2mm in diameter, a Single perforator is good to maintain the flap. LICAP has a dominant perforator in 6th-11th spaces, while LTAP has higher placed dominant perforators in 4th and 5th spaces. Methodology-Six consecutive patients who underwent reconstruction of the breast with pedicled perforator flaps were retrospectively analysed. Selections of the flap was done based on the size and locations of the tumour, anticipated volume loss, willingness to undergo contralateral symmetrisation, cosmetic expectations, and finances available.3 patients underwent vertical LTAP, the distal limit of the flap being the inframammary crease. 3 patients underwent MICAP, oriented along the axis of rib, the distal limit being the anterior axillary line. Preoperative identification was done using a unidirectional hand held doppler. The flap was raised caudal to cranial, the pivot point of rotation being the vessel entry into the skin. The donor area is determined by the skin pinch. Flap harvest time was 20-25 minutes. Intra operative vascularity was assessed with dermal bleed. The patient immediate pre, post-operative and follow up pics were compared independently by two breast surgeons. Patients were given a breast Q questionnaire (licensed) for scoring. Results-The median age of six patients was 46. Each patient had a hospital stay of 24 hours. None of the patients was willing for contralateral symmetrisation. The specimen dimensions were from 8x6.8x4 cm to 19x16x9 cm. The breast volume reconstructed range was 30 percent to 45 percent. All wide excision had free margins on frozen. The mean flap dimensions were 12x5x4.5 cm. One LTAP underwent marginal necrosis and delayed wound healing due to seroma. Three patients were phyllodes, of which one was borderline, and 2 were benign on final histopathology. All other 3 patients were invasive ductal cancer and have completed their radiation. The median follow up is 7 months the satisfaction scores at median follow of 7 months are 90 for physical wellbeing and 85 for surgical results. Surgeons scored fair to good in Harvard score. Conclusion- Pedicled perforator flaps are a valuable option for 3/8th volume of breast defects. LTAP is preferred for tumours at the Central, upper, and outer quadrants of the breast and MICAP for the inner and lower quadrant. The vascularity of the flap is dependent on the angiosomalterritories; adequate venous and cavity drainage.

Keywords: breast, oncoplasty, pedicled, perforator

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640 Xeroderma Pigmentosum Group G: Gene Polymorphism and Risk of Breast Cancer

Authors: Malik SS, Masood N, Mubarik S, Khadim TM

Abstract:

Introduction: Xeroderma pigmentosum group G (XPG) gene plays a crucial role in the correction of UV-induced DNA damage through nucleotide excision repair pathway. Single nucleotide polymorphisms in XPG gene have been reported to be associated with different cancers. Current case-control study was designed to evaluate the relationship between one of the most frequently found XPG (rs1047768 T>C) polymorphism and breast cancer risk. Methodology: A total of 200 individuals were screened for this polymorphism including 100 pathologically confirmed breast cancer cases and age-matched 100 controls. Genotyping was carried out using Tetra amplification-refractory mutation system (ARMS) PCR and results were confirmed by gel electrophoresis. Results: Conditional logistic regression analysis showed significant association between TC genotype (OR: 8.9, CI: 2.0 – 38.7) and increased breast cancer risk. Although homozygous CC genotype was more frequent in patients as compared to controls, but it was statistically non-significant (OR: 3.9, CI: 0.4 – 35.7). Conclusion: In conclusion, XPG (rs1047768 T>C) polymorphism may contribute towards increased risk of breast cancer but other polymorphisms may also be evaluated to elucidate their role in breast cancer.

Keywords: XPG, breast cancer, NER, ARMS-PCR

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639 Complications and Outcomes of Cochlear Implantation in Children Younger than 12 Months: A Multicenter Study

Authors: Alimohamad Asghari, Ahmad Daneshi, Mohammad Farhadi, Arash Bayat, Mohammad Ajalloueyan, Marjan Mirsalehi, Mohsen Rajati, Seyed Basir Hashemi, Nader Saki, Ali Omidvari

Abstract:

Evidence suggests that Cochlear Implantation (CI) is a beneficial approach for auditory and speech skills improvement in children with severe to profound hearing loss. However, it remains controversial if implantation in children <12 months is safe and effective compared to older children. The present study aimed to determine whether children's ages affect surgical complications and auditory and speech development. The current multicenter study enrolled 86 children who underwent CI surgery at <12 months of age (group A) and 362 children who underwent implantation between 12 and 24 months of age (group B). The Categories of Auditory Performance (CAP) and Speech Intelligibility Rating (SIR) scores were determined pre-impanation, and "one-year" and "two-year" post-implantation. Four complications (overall rate: 4.65%; three minor) occurred in group A and 12 complications (overall rate: 4.41%; nine minor) occurred in group B. We found no statistically significant difference in the complication rates between the groups (p>0.05). The mean SIR and CAP scores improved over time following CI activation in both groups. However, we did not find significant differences in CAP and SIR scores between the groups across different time points. Cochlear implantation is a safe and efficient procedure in children younger than 12 months, providing substantial auditory and speech benefits comparable to children undergoing implantation at 12 to 24 months of age. Furthermore, surgical complications in younger children are similar to those of children undergoing the CI at an older age.

Keywords: cochlear implant, Infant, complications, outcome

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638 A Randomized Active Controlled Clinical Trial to Assess Clinical Efficacy and Safety of Tapentadol Nasal Spray in Moderate to Severe Post-Surgical Pain

Authors: Kamal Tolani, Sandeep Kumar, Rohit Luthra, Ankit Dadhania, Krishnaprasad K., Ram Gupta, Deepa Joshi

Abstract:

Background: Post-operative analgesia remains a clinical challenge, with central and peripheral sensitization playing a pivotal role in treatment-related complications and impaired quality of life. Centrally acting opioids offer poor risk benefit profile with increased intensity of gastrointestinal or central side effects and slow onset of clinical analgesia. The objective of this study was to assess the clinical feasibility of induction and maintenance therapy with Tapentadol Nasal Spray (NS) in moderate to severe acute post-operative pain. Methods: Phase III, randomized, active-controlled, non-inferiority clinical trial involving 294 cases who had undergone surgical procedures under general anesthesia or regional anesthesia. Post-surgery patients were randomized to receive either Tapentadol NS 45 mg or Tramadol 100mg IV as a bolus and subsequent 50 mg or 100 mg dose over 2-3 minutes. The frequency of administration of NS was at every 4-6 hours. At the end of 24 hrs, patients in the tramadol group who had a pain intensity score of ≥4 were switched to oral tramadol immediate release 100mg capsule until the pain intensity score reduced to <4. All patients who had achieved pain intensity ≤ 4 were shifted to a lower dose of either Tapentadol NS 22.5 mg or oral Tramadol immediate release 50mg capsule. The statistical analysis plan was envisaged as a non-inferiority trial involving comparison with Tramadol for Pain intensity difference at 60 minutes (PID60min), Sum of Pain intensity difference at 60 minutes (SPID60min), and Physician Global Assessment at 24 hrs (PGA24 hrs). Results: The per-protocol analyses involved 255 hospitalized cases undergoing surgical procedures. The median age of patients was 38.0 years. For the primary efficacy variables, Tapentadol NS was non-inferior to Inj/Oral Tramadol in relief of moderate to severe post-operative pain. On the basis of SPID60min, no clinically significant difference was observed between Tapentadol NS and Tramadol IV (1.73±2.24 vs. 1.64± 1.92, -0.09 [95% CI, -0.43, 0.60]). In the co-primary endpoint PGA24hrs, Tapentadol NS was non–inferior to Tramadol IV (2.12 ± 0.707 vs. 2.02 ±0.704, - 0.11[95% CI, -0.07, 0.28). However, on further assessment at 48hr, 72 hrs, and 120hrs, clinically superior pain relief was observed with the Tapentadol NS formulation that was statistically significant (p <0.05) at each of the time intervals. Secondary efficacy measures, including the onset of clinical analgesia and TOTPAR, showed non-inferiority to Tramadol. The safety profile and need for rescue medication were also similar in both the groups during the treatment period. The most common concomitant medications were anti-bacterial (98.3%). Conclusion: Tapentadol NS is a clinically feasible option for improved compliance as induction and maintenance therapy while offering a sustained and persistent patient response that is clinically meaningful in post-surgical settings.

Keywords: tapentadol nasal spray, acute pain, tramadol, post-operative pain

Procedia PDF Downloads 255