Guideline Assessment Project II: statistical calibration informed the development of an AGREE II extension for surgical guidelines

OBJECTIVE: To inform the development of an AGREE II extension specifically tailored for surgical guidelines. AGREE II was designed to inform the development, reporting, and appraisal of clinical practice guidelines. Previous research has suggested substantial room for improvement of the quality of surgical guidelines. METHODS: A previously published search in MEDLINE for clinical practice guidelines published by surgical scientific organizations with an international scope between 2008 and 2017, resulted in a total of 67 guidelines. The quality of these guidelines was assessed using AGREE II. We performed a series of statistical analyses (reliability, correlation and Factor Analysis, Item Response Theory) with the objective to calibrate AGREE II for use specifically in surgical guidelines. RESULTS: Reliability/correlation/factor analysis and Item Response Theory produced similar results and suggested that a structure of 5 domains, instead of 6 domains of the original instrument, might be more appropriate. Furthermore, exclusion and re-arrangement of items to other domains was found to increase the reliability of AGREE II when applied in surgical guidelines. CONCLUSIONS: The findings of this study suggest that statistical calibration of AGREE II might improve the development, reporting, and appraisal of surgical guidelines

Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial

Laparoscopic surgery as an alternative to open surgery in patients with rectal cancer has not yet been shown to be oncologically safe. The aim in the COlorectal cancer Laparoscopic or Open Resection (COLOR II) trial was to compare laparoscopic and open surgery in patients with rectal cancer. A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries. Patients (aged ≥18 years) with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were randomly assigned to either laparoscopic or open surgery in a 2:1 ratio, stratified by centre, location of tumour, and preoperative radiotherapy. The study was not masked. Secondary (short-term) outcomes-including operative findings, complications, mortality, and results at pathological examination-are reported here. Analysis was by modified intention to treat, excluding those patients with post-randomisation exclusion criteria and for whom data were not available. This study is registered with ClinicalTrials.gov, number NCT00297791. The study was undertaken between Jan 20, 2004, and May 4, 2010. 1103 patients were randomly assigned to the laparoscopic (n=739) and open surgery groups (n=364), and 1044 were eligible for analyses (699 and 345, respectively). Patients in the laparoscopic surgery group lost less blood than did those in the open surgery group (median 200 mL [IQR 100-400] vs 400 mL [200-700], p <0·0001); however, laparoscopic procedures took longer (240 min [184-300] vs 188 min [150-240]; p <0·0001). In the laparoscopic surgery group, bowel function returned sooner (2·0 days [1·0-3·0] vs 3·0 days [2·0-4·0]; p <0·0001) and hospital stay was shorter (8·0 days [6·0-13·0] vs 9·0 days [7·0-14·0]; p=0·036). Macroscopically, completeness of the resection was not different between groups (589 [88%] of 666 vs 303 [92%] of 331; p=0·250). Positive circumferential resection margin ( <2 mm) was noted in 56 (10%) of 588 patients in the laparoscopic surgery group and 30 (10%) of 300 in the open surgery group (p=0·850). Median tumour distance to distal resection margin did not differ significantly between the groups (3·0 cm [IQR 2·0-4·8] vs 3·0 cm [1·8-5·0], respectively; p=0·676). In the laparoscopic and open surgery groups, morbidity (278 [40%] of 697 vs 128 [37%] of 345, respectively; p=0·424) and mortality (eight [1%] of 699 vs six [2%] of 345, respectively; p=0·409) within 28 days after surgery were similar. In selected patients with rectal cancer treated by skilled surgeons, laparoscopic surgery resulted in similar safety, resection margins, and completeness of resection to that of open surgery, and recovery was improved after laparoscopic surgery. Results for the primary endpoint-locoregional recurrence-are expected by the end of 2013. Ethicon Endo-Surgery Europe, Swedish Cancer Foundation, West Gothia Region, Sahlgrenska University Hospita

COVID-19 and laparoscopic surgery: Scoping review of current literature and local expertise

Background: The current coronavirus disease (COVID-19) pandemic is holding the world in its grip. Epidemiologists have shown that the mortality risks are higher when the health care system is subjected to pressure from COVID-19. It is therefore of great importance to maintain the health of health care providers and prevent contamination. An important group who will be required to treat patients with COVID-19 are health care providers during semiacute surgery. There are concerns that laparoscopic surgery increases the risk of contamination more than open surgery; therefore, balancing the safety of health care providers with the benefit of laparoscopic surgery for the patient is vital. Objective: We aimed to provide an overview of potential contamination routes and possible risks for health care providers; we also aimed to propose research questions based on current literature and expert opinions about performing laparoscopic surgery on patients with COVID-19. Methods: We performed a scoping review, adding five additional questions concerning possible contaminating routes. A systematic search was performed on the PubMed, CINAHL, and Embase databases, adding results from gray literature as well. The search not only included COVID-19 but was extended to virus contamination in general. We excluded society and professional association statements about COVID-19 if they did not add new insights to the available literature. Results: The initial search provided 2007 records, after which 267 full-text papers were considered. Finally, we used 84 papers, of which 14 discussed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Eight papers discussed the added value of performing intubation in a low-pressure operating room, mainly based on the SARS outbreak experience in 2003. Thirteen papers elaborated on the risks of intubation for health care providers and SARS-CoV-2, and 19 papers discussed this situation with other viruses. They conclude that there is significant evidence that intubation and extubation is a high-risk aerosol-producing procedure. No papers were found on the risk of SARS-CoV-2 and surgical smoke, although 25 papers did provide conflicting evidence on the infection risk of human papillomavirus, hepatitis B, polio, and rabies. No papers were found discussing tissue extraction or the deflation risk of the pneumoperitoneum after laparoscopic surgery. Conclusions: There seems to be consensus in the literature that intubation and extubation are high-risk procedures for health care providers and that maximum protective equipment is needed. On the other hand, minimal evidence is available of the actual risk of contamination of health care providers during laparoscopy itself, nor of operating room pressure, surgical smoke, tissue extraction, or CO2 deflation. However, new studies are being published daily from current experiences, and society statements are continuously updated. There seems to be no reason to abandon laparoscopic surgery in favor of open surgery. However, the risks should not be underestimated, surgery should be performed on patients with COVID-19 only when necessary, and health care providers should use logic and common sense to protect themselves and others by performing surgery in a safe and protected environment

Insight into the methodology and uptake of EAES guidelines: a qualitative analysis and survey by the EAES Consensus & Guideline Subcommittee

Background: Over the past 25 years, the European Association for Endoscopic Surgery (EAES) has been issuing clinical guidance documents to aid surgical practice. We aimed to investigate the awareness and use of such documents among EAES members. Additionally, we conceptually appraised the methodology used in their development in order to propose a bundle of actions for quality improvement and increased penetration of clinical practice guidelines among EAES members. Methods: We invited members of EAES to participate in a web-based survey on awareness and use of these documents. Post hoc analyses were performed to identify factors associated with poor awareness/use and the reported reasons for limited use. We further summarized and conceptually analyzed key methodological features of clinical guidance documents published by EAES. Results: Three distinct consecutive phases of methodological evolvement of clinical guidance documents were evident: a “consensus phase,” a “guideline phase,” and a “transitional phase”. Out of a total of 254 surgeons who completed the survey, 72% percent were aware of EAES guidelines and 47% reported occasional use. Young age and trainee status were associated with poor awareness and use. Restriction by colleagues was the primary reason for limited use in these subgroups. Conclusions: The methodology of EAES clinical guidance documents is evolving. Awareness among EAES members is fair, but use is limited. Dissemination actions should be directed to junior surgeons and trainees

Same-Day Discharge After Laparoscopic Roux-en-Y Gastric Bypass: a Cohort of 500 Consecutive Patients

Introduction: There is an increasing demand on hospital capacity worldwide due to the COVID-19 pandemic and local staff shortages. Novel care pathways have to be developed in order to keep bariatric and metabolic surgery maintainable. Same-day discharge (SDD) after laparoscopic Roux-en-Y gastric bypass (RYGB) is proved to be feasible and could potentially solve this challenge. The aim of this study was to investigate whether SDD after RYGB is safe for a selected group of patients. Methods: In this single-center cohort study, low-risk patients were selected for primary RYGB with intended same-day discharge with remote monitoring. All patients were operated according to ERAS protocol. There were strict criteria on approval upon same-day discharge. It was demanded that patients should contact the hospital in case of any signs of complications. Primary outcome was the rate of successful same-day discharge without readmission within 48?h. Secondary outcomes included short-term complications, emergency department visits, readmissions, and mortality. Results: Five hundred patients underwent RYGB with intended SDD, of whom 465 (93.0%) were successfully discharged. Twenty-one patients (4.5%) were readmitted in the first 48?h postoperatively. None of these patients had a severe bleeding. This results in a success rate of 88.8% of SDD without readmission within 48?h. Conclusions: Same-day discharge after RYGB is safe, provided that patients are carefully selected and strict discharge criteria are used. It is an effective care pathway to reduce the burden on hospital capacity. Graphical Abstract: [Figure not available: see fulltext.

Optimal stump management in laparoscopic appendectomy: A network meta-analysis by the Minimally Invasive Surgery Synthesis of Interventions and Outcomes Network

Background: Laparoscopic appendectomy is the predominant method of treatment of acute appendicitis. There is insufficient evidence on the most effective management of the appendix stump. The aim of this study was to investigate the relative effectiveness and provide a treatment ranking of different options for securing the appendix stump. Methods: Electronic databases were searched to identify randomized controlled trials comparing ligation methods of the appendix. The primary outcomes were organ/space infection and superficial operative site infection. We performed a network meta-analysis and estimated the pairwise relative treatment effects of the competing interventions using the odds ratio and its 95% confidence interval. We obtained a hierarchy of the competing interventions using rankograms and the surface under the cumulative ranking curve. Results: Forty-three randomized controlled trials were eligible and provided data for >5,000 patients. Suture ligation seemed to be the most effective treatment strategy, in terms of both organ/space infection and superficial operative site infection. Statistical significance was reached for the comparisons of clip versus endoloop (odds ratio 0.56, 95% confidence interval, 0.32-0.96) for organ/space infection; and suture versus clip (odds ratio 0.20, 95% confidence interval 0.08-0.55) and clip versus endoloop (odds ratio 2.22, 95% confidence interval 1.56-3.13) for superficial operative site infection. The network was informed primarily by indirect treatment comparisons. Conclusion: The use of suture ligation of the appendix in laparoscopic appendectomy seems to be superior to other methods for the composite parameters of organ/space and superficial operative site infection

Guideline Assessment Project II: statistical calibration informed the development of an AGREE II extension for surgical guidelines

Objective: To inform the development of an AGREE II extension specifically tailored for surgical guidelines. Summary background data: AGREE II was designed to inform the development, reporting, and appraisal of clinical practice guidelines. Previous research has suggested substantial room for improvement of the quality of surgical guidelines. Methods: A previously published search in MEDLINE for clinical practice guidelines published by surgical scientific organizations with an international scope between 2008 and 2017, resulted in a total of 67 guidelines. The quality of these guidelines was assessed using AGREE II. We performed a series of statistical analyses (reliability, correlation and Factor Analysis, Item Response Theory) with the objective to calibrate AGREE II for use specifically in surgical guidelines. Results: Reliability/correlation/factor analysis and Item Response Theory produced similar results and suggested that a structure of 5 domains, instead of 6 domains of the original instrument, might be more appropriate. Furthermore, exclusion and re-arrangement of items to other domains was found to increase the reliability of AGREE II when applied in surgical guidelines. Conclusions: The findings of this study suggest that statistical calibration of AGREE II might improve the development, reporting, and appraisal of surgical guidelines

Guideline assessment project II: statistical calibration informed the development of an AGREE II extension for surgical guidelines

Objective: To inform the development of an AGREE II extension specifically tailored for surgical guidelines. Summary background data: AGREE II was designed to inform the development, reporting, and appraisal of clinical practice guidelines. Previous research has suggested substantial room for improvement of the quality of surgical guidelines. Methods: A previously published search in MEDLINE for clinical practice guidelines published by surgical scientific organizations with an international scope between 2008 and 2017, resulted in a total of 67 guidelines. The quality of these guidelines was assessed using AGREE II. We performed a series of statistical analyses (reliability, correlation and Factor Analysis, Item Response Theory) with the objective to calibrate AGREE II for use specifically in surgical guidelines. Results: Reliability/correlation/factor analysis and Item Response Theory produced similar results and suggested that a structure of 5 domains, instead of 6 domains of the original instrument, might be more appropriate. Furthermore, exclusion and re-arrangement of items to other domains was found to increase the reliability of AGREE II when applied in surgical guidelines. Conclusions: The findings of this study suggest that statistical calibration of AGREE II might improve the development, reporting, and appraisal of surgical guidelines