Muhammad Nurhadi Rahman, Siswanto Agus Wilopo, Ova Emilia
{"title":"The Efficacy of Divabirth Vaginal Dilator to Prevent Pelvic Floor Trauma During Labor: A Protocol Study.","authors":"Muhammad Nurhadi Rahman, Siswanto Agus Wilopo, Ova Emilia","doi":"10.29337/ijsp.179","DOIUrl":"https://doi.org/10.29337/ijsp.179","url":null,"abstract":"<p><strong>Background: </strong>Vaginal birth may have a negative impact on nerve structure and function, pelvic floor muscle structure, and function. Reducing the risk of pelvic floor injuries during vaginal birth is one of the most effective ways to prevent labor morbidity in women. There is a lack of tools developed based on this approach, especially in Indonesia. Therefore, we aimed to know the efficacy of a vaginal dilator called Divabirth based on labor outcomes.</p><p><strong>Methods: </strong>This clinical study involved subjects who are randomly grouped in to the control and treatment groups. Subjects in the treatment group are told to utilize vaginal dilator devices for 20 minutes each session, a maximum of two sessions per day, lasting 5 minutes every cycle, from 35 weeks of gestation until delivery.</p><p><strong>Discussions: </strong>The current research contributes valuable information to developing a vaginal dilator intervention program for pregnant women to reduce perineal laceration and improve labor outcomes. It may also help to lower their medical and treatment expenditures. We expect its success to be a step forward in improving reproductive health status.</p><p><strong>Highlights: </strong>Vaginal birth may have negative impact on nerve and pelvic floor muscle structure and functionLack of tool has been developed to reduce the risk of pelvic floor injuries during vaginal birthA study protocol of vaginal dilator usage to know the efficacy based on labor outcomes.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"88-93"},"PeriodicalIF":0.9,"publicationDate":"2022-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9635326/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40469052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Development of Surgical Error Reduction System (SERS) for Laparoscopic Appendectomy by using Observational Human Reliability Analysis (OCHRA) model and to analyse its impact on patient outcomes.","authors":"Girivasan Muthukumarasamy, Samer Zino, Benjie Tang, Pradeep Patil","doi":"10.29337/ijsp.181","DOIUrl":"https://doi.org/10.29337/ijsp.181","url":null,"abstract":"<p><p>This project is to develop a surgical error reduction system (SERS) for laparoscopic appendectomy by using observational Human Reliability Analysis (OCHRA) model and to analyse it impact on patient's outcome.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"26 1","pages":"81-87"},"PeriodicalIF":0.9,"publicationDate":"2022-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9503951/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33497357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
S Makineli, M D Filipe, F Euwe, A Sakes, J Dankelman, P Breedveld, M R Vriens, P J van Diest, A J Witkamp
{"title":"Feasibility of Narrow-Band Imaging, Intraductal Biopsy, and Laser Ablation During Mammary Ductoscopy: Protocol for an Interventional Study.","authors":"S Makineli, M D Filipe, F Euwe, A Sakes, J Dankelman, P Breedveld, M R Vriens, P J van Diest, A J Witkamp","doi":"10.29337/ijsp.180","DOIUrl":"https://doi.org/10.29337/ijsp.180","url":null,"abstract":"<p><strong>Introduction: </strong>Ductoscopy is a minimally invasive micro-endoscopic approach for direct visualization of intraductal lesions of the breast. Challenges of ductoscopy are low sensitivity for detecting malignancy, the lack of a proper intraductal biopsy device, and adequate treatment of intraductal lesions. This study will analyze three new approaches to enhance the effectiveness of interventional ductoscopy in patients with (premalignant) intraductal lesions: narrow-band imaging (NBI), new intraductal biopsy tools, and intraductal laser ablation. The main aims of the present study are to improve diagnostic accuracy and therapeutic efficacy of interventional ductoscopy in patients with pathological nipple discharge (PND) and to explore the feasibility of the new approaches in diagnosing and removing intraductal precursor lesions.</p><p><strong>Methods and analysis: </strong>This prospective, single-center, diagnostic feasibility study will include two patient groups. <i>Group A</i>: women with PND with no radiological suspicion for malignancy. <i>Group B</i>: women undergoing mastectomy (preventive or therapeutic). The primary endpoints for both groups are the technical feasibility of NBI ductoscopy, intraductal biopsy, and laser ablation, and as secondary endpoint the number of diagnosed and successfully treated intraductal lesions.</p><p><strong>Discussion: </strong>Enhanced ductoscopy with NBI, intraductal biopsy, and laser ablation could prevent unnecessary surgery in patients with PND.</p><p><strong>Ethics and dissemination: </strong>This study was approved by the Medical Research Ethics Committee UMC Utrecht in The Netherlands (METC protocol number 21-688/H-D). The results of this study will be published in peer-reviewed journals and presented at national and international conferences.</p><p><strong>Highlights: </strong>- Pathological nipple discharge (PND) is a common breast-related complaint in women.- Ductoscopy, a minimally invasive technique, is used in the treatment of PND.- This study will analyze three new approaches to enhance interventional ductoscopy of the breast: narrow-band imaging, new intraductal biopsy tools, and intraductal laser ablation in patients with (premalignant) intraductal lesions.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"73-80"},"PeriodicalIF":0.9,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9438461/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40364453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Robertino B Basso, Breyner Garcia Rodriguez, René M Palacios Huatuco, Alejandro Coloccini, Mariano F Ramírez, Horacio F Mayer
{"title":"Usefulness of Glucose Measurement To Assess Tissue Perfusion of the Nipple-Areola Complex in Conservative Mastectomy: A Prospective Cohort Study Protocol.","authors":"Robertino B Basso, Breyner Garcia Rodriguez, René M Palacios Huatuco, Alejandro Coloccini, Mariano F Ramírez, Horacio F Mayer","doi":"10.29337/ijsp.178","DOIUrl":"https://doi.org/10.29337/ijsp.178","url":null,"abstract":"<p><p>In recent decades, the mastectomy technique has undergone progressive adaptations in order to preserve the integrity of the breast structure and the nipple-areola complex (NAC), allowing reconstruction to be performed immediately after ablation. However, mastectomy flap necrosis or NAC has become a common complication, with an incidence between 2% and 22.3%. Blood glucose measurement to monitor microsurgical flaps has been reported as a simple method for the early detection of venous compromise. In this scenario, we propose the need to use an alternative, cost-effective method to assess the vitality of NAC in conservative oncological mastectomies. This protocol describes a prospective cohort study and was approved by the Research Protocols Ethics Committee of our institution. Patients will be included after signing informed consent. The anonymity and confidentiality of the information collected will be respected according to the Declaration of Helsinki and according to local and national guidelines.</p><p><strong>Highlights: </strong>The rate of flap necrosis or nipple-areola complex (NAC) after mastectomy with reconstruction ranges from 2% to 22.3%.Glucose measurement has been reported in microsurgical flaps.This protocol seeks to determine the use of glucose as an early predictor of NAC necrosis.Participants will be recruited from a high-volume breast pathology hospital.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"68-72"},"PeriodicalIF":0.9,"publicationDate":"2022-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9354559/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40621237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rituja Kamble, Rushabh Shah, Ailbhe L Kiely, Grant S Nolan, Jason Wong
{"title":"Secondary Flexor Tendon Reconstruction: Protocol for a Systematic Review and Meta-Analysis.","authors":"Rituja Kamble, Rushabh Shah, Ailbhe L Kiely, Grant S Nolan, Jason Wong","doi":"10.29337/ijsp.176","DOIUrl":"https://doi.org/10.29337/ijsp.176","url":null,"abstract":"<p><strong>Introduction: </strong>Flexor tendon injuries of the hand and wrist involve complete or partial severance of the tendon, and primary repair is standard treatment. In cases of significantly delayed presentation, rupture of the repair or segmental tendon loss may require 1- or 2-stage secondary tendon reconstruction where a tendon graft is used. There is a risk of poor functional outcome due to stiffness and reduced range of motion which may affect patient's employment and activities of daily living. This study seeks to systematically evaluate the current evidence to determine outcomes of secondary flexor tendon reconstruction in terms of functional outcomes, complications, patient-reported outcome measures (PROMS) and costs.</p><p><strong>Methods: </strong>This is a PROSPERO registered study protocol for systematic review and meta-analysis of comparative and non-comparative studies. Outcomes of intrasynovial versus extrasynovial tendon grafting and seniority of the surgeon will be analysed in addition to comparing graft weaving at the wrist and palm for both single- and two-stage tendon reconstruction. The primary outcome is functional active range of motion. Secondary outcomes are complications, PROMs and resource use. A comprehensive literature search will be conducted from 2000 to present. All studies involving secondary flexor tendon repairs will be involved, without limitation on language, and will be screened by two independent reviewers. Tools to appraise the quality of study methodology and/or bias will be used (e.g., Cochrane Collaborative Risk of Bias tool) and if feasible, a random effects meta-analysis will be conducted.</p><p><strong>Ethics and dissemination: </strong>Ethical approval was not required for this study. The results of this systematic review and meta-analysis will be published in a peer-reviewed journal, and presented at both national and international conferences involving hand surgeons. The data collected will allow patients to be counselled more accurately by clinicians and may suggest areas where further research could be undertaken.</p><p><strong>Systematic review registration: </strong>PROSPERO CRD42021296009.</p><p><strong>Highlights: </strong>Single- or two-stage secondary flexor tendon reconstruction is an important treatment modality in cases unsuitable for primary repair.This study seeks to systematically evaluate the current evidence to determine outcomes of secondary flexor tendon reconstruction in terms of functional. outcomes, complications, patient-reported outcome measures (PROMS) and costs.This is a PROSPERO registered study protocol for systematic review and meta-analysis of comparative and non-comparative studies.Outcomes of intrasynovial versus extrasynovial tendon grafting and seniority of the surgeon will be analysed in addition to comparing graft weaving at the wrist and palm for both single- and two-stage tendon reconstruction.This systematic review aims to evaluate and summarise the be","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"49-56"},"PeriodicalIF":0.9,"publicationDate":"2022-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9266938/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40540092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Hemocoagulative Modifications after Laparoscopic Surgery at Different Pneumoperitoneum Pressure Settings.","authors":"Intagliata Eva, Vecchio Rosario, Saitta Cesare, Vizzini Clarissa, Lo Presti Federica, Cacciola Rossella Rosaria, Cacciola Emma, Vecchio Veronica","doi":"10.29337/ijsp.173","DOIUrl":"https://doi.org/10.29337/ijsp.173","url":null,"abstract":"<p><strong>Background: </strong>Many of the effects of pneumoperitoneum on cardiovascular, respiratory and metabolic systems have been discussed in Literature, but very little is known about the variations of the hemocoagulative parameters in patients undergoing laparoscopic surgery. The purpose of this study is to analyze the variations of the hemocoagulative parameters in patients undergoing elective laparoscopic cholecystectomy for symptomatic gallbladder stones. An eventual statistically significant difference linked to different pressure settings of pneumoperitoneum will allow selecting a specific intrabdominal pressure for a more adequate treatment with a lower incidence of pneumoperitoneum related complications.</p><p><strong>Materials and methods: </strong>The clinical trial was conducted on 43 patients assigned in two groups based on the intra-abdominal pressure: group A, 27 patients, 12 mmHg, and group B, 16 patients, 8 mmHg. Hemoglobin, hematocrit, platelets count, PT ratio, aPTT, Fibrinogen, D-dimer, Von Willebrand factor, Factor II, Lupus Anticoagulant, Antithrombin III, Protein C, Protein S, Anticardiolipin IgG and IgM, anti-beta 2-Glicoprotein IgG and IgM were evaluated.</p><p><strong>Results: </strong>For group A, patient's variations were observed for D-dimer, Factor II, von Willembrand factor and protein C reactive, while for patients belonging to group B the parameters most affected were PT ratio, anti-thrombin III and protein C reactive.D-dimer values increased significantly in group A, a statistically significant decrease in anti-thrombin III levels was detected in group B, and a statistically significant difference in PT ratio in patients belonging to group B was observed.</p><p><strong>Conclusion: </strong>The statistical analysis showed no significant difference in the post-operative parameters when comparing the two groups of patients. Alterations of the coagulation parameters were present between pre- and post-operative data within the same group, namely a higher abdominal pressure is linked to a prothrombotic state. The question is worthy of further studies.</p><p><strong>Highlights: </strong>- Variations of the hemocoagulative parameters in patients undergoing laparoscopy are still a matter of study;- Pneumoperitoneum seems to cause alterations in the hemocoagulative parameters, which could be influenced by the pneumoperitoneum pressure;- An eventual statistically significant difference linked to different pressure settings of pneumoperitoneum will allow selecting a specific intrabdominal pressure for a more adequate surgical treatment with a lower incidence of pneumoperitoneum related complications.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"41-48"},"PeriodicalIF":0.9,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9205367/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40570100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Fiorenzo V Angehrn, Kerstin J Neuschütz, Johannes Baur, Romano Schneider, Alexander Wilhelm, Lea Stoll, Julian Süsstrunk, Markus von Flüe, Martin Bolli, Daniel C Steinemann
{"title":"Robotic Versus Conventional Minimal-Invasive Inguinal Hernia Repair: Study Protocol for a Prospective, Randomized and Blinded Clinical Trial.","authors":"Fiorenzo V Angehrn, Kerstin J Neuschütz, Johannes Baur, Romano Schneider, Alexander Wilhelm, Lea Stoll, Julian Süsstrunk, Markus von Flüe, Martin Bolli, Daniel C Steinemann","doi":"10.29337/ijsp.175","DOIUrl":"https://doi.org/10.29337/ijsp.175","url":null,"abstract":"<p><strong>Introduction: </strong>Inguinal hernia repairs are commonly performed procedures. The surgical techniques vary from open procedures to minimally invasive and robotic-assisted surgeries and include totally extra-peritoneal hernia repairs (TEP) and robotic transabdominal pre-peritoneal hernia repairs (rTAPP). So far, there is no randomized and blinded clinical trial comparing these two surgical approaches. Our objective is to investigate whether rTAPP is associated with a decreased postoperative level of pain.</p><p><strong>Methods: </strong>This is a prospective, single center, randomized and blinded clinical trial. Patients will receive either rTAPP or TEP for uni- or bilateral inguinal hernias. All patients and assessors of the study are blinded to the randomization. The perioperative setting is standardized, and all surgeons will perform both rTAPP and TEP to eliminate surgeons` bias. Primary endpoint is the assessment of pain while coughing 24 hours after surgery using the numeric rating scale (NRS). Secondary endpoints include the assessment of multiple pain and quality of life questionnaires at several defined times according to the study schedule. Furthermore, intra- and postoperative complications, duration until discharge, procedure time, duration of postoperative sick leave and the recurrence rate will be evaluated.</p><p><strong>Registry: </strong>The trial has been registered at ClinicalTrials.gov under the registry number NCT05216276.</p><p><strong>Highlights: </strong>Trial comparing robotic and conventional minimal-invasive inguinal hernia repairRandomized and patient/assessor blinded trialEarly postoperative pain as primary outcome (24 hours)Secondary patient outcomes include pain and quality of life scores up to one yearFurther secondary outcomes: complications, costs, surgeon's stress level.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"27-34"},"PeriodicalIF":0.9,"publicationDate":"2022-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9187240/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40565603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Clinical Effectiveness of Various Surgical Reconstruction Modalities for Acute ACJ Separation: Protocol for a Systematic Review and Meta-Analysis","authors":"A. Hartland, S. Nayar, K. H. Teoh, M. Rashid","doi":"10.29337/ijsp.172","DOIUrl":"https://doi.org/10.29337/ijsp.172","url":null,"abstract":"Introduction: Acute acromioclavicular joint separation is a common injury to the shoulder. Various surgical reconstruction methods exist when operative management is required, but the optimal procedure is not known. The aim of this systematic review and meta-analysis is to review the literature to assess the clinical effectiveness of various surgical reconstruction modalities used for acute ACJ separation. Methods: The study protocol was designed and registered prospectively on PROSPERO (International prospective register for systematic reviews). Literature search will include MEDLINE, EMBASE, PsycINFO, and The Cochrane Library electronic databases. Randomised controlled trials (RCTs) evaluating surgical procedures for acute acromioclavicular joint (ACJ) separation will be included. Our primary outcome is any functional patient-reported outcome measure related to the shoulder. Secondary outcomes may include radiological measurements, objective measurements of strength testing, range of motion, other patient-reported outcome measures not specific to the shoulder such as the Visual-Analog Scale (VAS) for pain, timelines for return to sport or work, and rate of complications. Risk of bias will be assessed within each study using The Cochrane Risk of Bias Tool 2.0 and the Jadad score. Inconsistency and bias across included studies will be assessed statistically. Comparable outcome data will be pooled and analysed quantitatively or qualitatively as appropriate. Ethics and dissemination: This study did not require ethical clearance. We plan to publish this systematic review and meta-analysis in a peer-reviewed journal and present the results at various national and international conferences. Highlights There is currently variation in surgical synthetic ligament reconstruction techniques for acute acromioclavicular separation, with no clear consensus established. This systematic review evaluates the clinical effectiveness of various surgical reconstruction modalities used for acute ACJ separation. Our primary outcome is any functional patient-reported outcome measure related to the shoulder.","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"26 1","pages":"22 - 26"},"PeriodicalIF":0.9,"publicationDate":"2022-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48986609","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Omer Al-Yahri, R. Al‐Zoubi, Azza Alam Elhuda, Amina Ahmad, M. Al Dhaheri, S. Abdelaziem, M. Alwani, A. Al-Qudimat, Ahmad Zarour
{"title":"Diagnostic Inflammation Biomarkers for Prediction of 30-Day Mortality Rate in Acute Cholangitis","authors":"Omer Al-Yahri, R. Al‐Zoubi, Azza Alam Elhuda, Amina Ahmad, M. Al Dhaheri, S. Abdelaziem, M. Alwani, A. Al-Qudimat, Ahmad Zarour","doi":"10.29337/ijsp.170","DOIUrl":"https://doi.org/10.29337/ijsp.170","url":null,"abstract":"Background: Acute cholangitis (AC) is an acute inflammation and infection of the biliary tract, a potentially life-threatening infection, which is usually associated with biliary tree obstruction and impairment of bile flow from the liver to the duodenum. AC is classified by severity from mild, moderate to severe infection (grade I to III, respectively). Methods: This study recruited a retrospective cohort from Jan 2015 to July 2018. Overall, 294 patients of age ≥ 18 years with AC were enrolled. The study was conducted according to the World Medical Association Declaration of Helsinki. Demographic and laboratory data were collected for analysis. T-Bilirubin and other laboratory results were collected and analyzed using independent T-test and ANOVA for continuous values and multivariate COX regression for survival analysis for identifying independent factors for early mortality. The cut-off threshold of T-bilirubin was determined by calculating the area under the receiver operating characteristic (ROC) curve. Results: There were 213 male and 81 female patients and mean age ± SD of patients was 49.57 ± 16.1 and 56.12 ± 20.18 respectively. 31.9% patients were found older than 60 years of age and 35% patients were found between 30–45 years of age. T-bilirubin and length of hospital stay (LOS) were found statistically significant (P < 0.05) in relation to mortality in AC patients. The area under ROC curve for T-bilirubin level (P = 0.017, OR = 1.010) was 0.717 (95% CI, 6.25–168.9) and this is consistent with the Cut-off point for more than or equal to 38.6 µmol/L (2.26 mg/dL). Conclusions: In this study, T-bilirubin level is found to be significantly related to short-term mortality in AC. Further studies are still needed with larger cohorts to shed more light on these findings. Highlights: Herein, we report a retrospective observational study aiming to evaluate biomarkers contributing to mortality in AC and to determine the cut-off diagnostic levels that could be easily used in emergency setting. Overall, 294 patients of age ≥ 18 years with AC were enrolled. The study was conducted according to the World Medical Association Declaration of Helsinki and approved by Institutional Review Board (IRB) with approval: MRC-01-20-823 at Hamad Medical Corporation (HMC). Demographic and laboratory data were collected for analysis. Total-Bilirubin and other laboratory results were collected and analyzed using independent T-test and ANOVA for continuous values and multivariate COX regression for survival analysis for identifying independent factors for early mortality. The cut-off threshold of T-bilirubin was determined by calculating the area under the receiver operating characteristic (ROC) curve. There were 213 male and 81 female patients and mean age ± SD of patients was 49.57 ± 16.1 and 56.12 ± 20.18 respectively. 31.9% patients were found older than 60 years of age and 35% patients were found between 30-45 years of age. T-bilirubin and length of hospital stay","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"26 1","pages":"14 - 21"},"PeriodicalIF":0.9,"publicationDate":"2022-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41643735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
R. Jootun, Pedja Cuk, M. Ellebæk, P. V. Andersen, S. Salomon, G. Baatrup, I. Al-Najami, J. Khan
{"title":"Robotic vs. TaTME Rectal Surgery (ROTA STUDY) Matched Cohort Trial for Mid to Low Rectal Cancer Surgery Evaluation Trial in the Hands of an Experienced Surgeon","authors":"R. Jootun, Pedja Cuk, M. Ellebæk, P. V. Andersen, S. Salomon, G. Baatrup, I. Al-Najami, J. Khan","doi":"10.29337/ijsp.163","DOIUrl":"https://doi.org/10.29337/ijsp.163","url":null,"abstract":"Background: Recent novel surgical techniques for resection of low rectal cancer have been introduced and these approaches have the potential to overcome anatomical limitations like obesity, narrow male pelvis and bulky and low tumours. Two of these procedures are robotic low anterior resection (RLAR) and transanal total mesorectal excision (TaTME). Both approaches have distinct advantages and limitations. There has been no head to head trial comparing RLAR and TaTME for patients with mid to low rectal cancer undergoing surgery by experienced surgeons. Previous studies looking at the oncological outcomes of either TaTME or robotic TME included many centres where the surgeons were on a learning curve and hence the true oncological outcomes and clinical benefits can not be measured accurately. Method: The inclusion criteria include experienced surgeons defined as minimum of 60 prior procedures with RLAR or TaTME. Successful oncological and clinical outcomes are defined as circumferential resection margin (CRM) ≥1 mm with limited postoperative morbidity (absence of Clavien-Dindo grade III–IV complications within 30 days after surgery). Local and distal recurrence rates with DFS over 3 years will be measured as primary outcome. Data will be collected prospectively and entered in a dedicated database. Discussion: The primary objective of this study is to conduct a multicentre prospective trial to investigate clinical outcomes, in particular disease free survival (DFS) in patients undergoing RLAR and TaTME. The additional goal is to investigate other efficacy measures, complications rates, health economic aspects and patient reported health related quality of life. This paper describes an important trial conducted in expert centres to establish the needed knowledge for a detailed comparison of outcomes for TaTME versus RLAR. This trial is the first comparative study, comparing TaTME and RLAR, seeking to establish foothold for tailor-made surgical treatment of low rectal cancer patients. Trial registration: The trial is registered in clinicaltrials.gov September 2019. Clinicaltrials.gov id: NCT04200027.","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"26 1","pages":"7 - 13"},"PeriodicalIF":0.9,"publicationDate":"2022-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48646071","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}