National implementation of an optimal standardised technique for right-sided colon cancer:protocol of an interventional sequential cohort study (Right study)

Purpose: Minimally invasive right hemicolectomy (MIRH) is the cornerstone of treatment for patients with right-sided colon cancer. This operation has evolved during recent decades, with many innovations and improvements but this has also resulted in high variability of uptake with subsequent substantial variableness. The aim of this ongoing study is to identify current surgical variations, determine the most optimal and standardised MIRH and nationally train and implement that technique to improve short-term clinical and long-term oncological outcomes. Methods: The Right study is a national multicentre prospective interventional sequential cohort study. Firstly, current local practice was evaluated. Subsequently, a standardised surgical technique for right-sided colon cancer was determined using the Delphi consensus method, and this procedure was trained during hands-on courses. The standardised MIRH will be implemented with proctoring (implementation cohort), after which the performance will be monitored (consolidation cohort). Patients who will receive a minimally invasive (extended) right hemicolectomy for cT1-3N0-2M0 colon cancer will be included. The primary outcome is patient safety reflected in the 90-day overall complication rate according to the Clavien–Dindo classification. Secondary outcomes will include intraoperative complications, 90-day mortality rate, number of resected tumour-positive lymph nodes, completeness of mesocolic excision, surgical quality score, locoregional and distant recurrence and 5-year overall survival. A total number of 1095 patients (365 per cohort) will be included. Discussion: The Right study is designed to safely implement the best surgical practice concerning patients with right-sided colon cancer aiming to standardise and improve the surgical quality of MIRH at a national level. Trial registration: ClinicalTrials.gov: NCT04889456, May 2021.</p

Standard Outpatient Re-Evaluation for Patients Not Admitted to the Hospital After Emergency Department Evaluation for Acute Abdominal Pain

The aim of the present study was to investigate the efficacy and safety of standard outpatient re-evaluation for patients who are not admitted to the hospital after emergency department surgical consultation for acute abdominal pain. All patients seen at the emergency department between June 2005 and July 2006 for acute abdominal pain were included in a prospective study using a structured diagnosis and management flowchart. Patients not admitted to the hospital were given appointments for re-evaluation at the outpatient clinic within 24 h. All clinical parameters, radiological results, diagnostic considerations, and management proposals were scored prospectively. Five-hundred patients were included in this analysis. For 148 patients (30%), the final diagnosis was different from the diagnosis after initial evaluation. Eighty-five patients (17%) had a change in management after re-evaluation, and 20 of them (4%) were admitted to the hospital for an operation. Only 6 patients (1.2%) had a delay in diagnosis and treatment, which did not cause extra morbidity. Standard outpatient re-evaluation is a safe and effective means of improving diagnostic accuracy and helps to adapt management for patients that are not admitted to the hospital after surgical consultation for acute abdominal pain at the emergency department.Vascular Surger

2 days versus 5 days of postoperative antibiotics for complex appendicitis:a pragmatic, open-label, multicentre, non-inferiority randomised trial

Background: The appropriate duration of postoperative antibiotics for complex appendicitis is unclear. The increasing global threat of antimicrobial resistance warrants restrictive antibiotic use, which could also reduce side-effects, length of hospital stay, and costs. Methods: In this pragmatic, open-label, non-inferiority trial in 15 hospitals in the Netherlands, patients with complex appendicitis (aged ≥8 years) were randomly assigned (1:1) to receive 2 days or 5 days of intravenous antibiotics after appendicectomy. Randomisation was stratified by centre, and treating physicians and patients were not masked to treatment allocation. The primary endpoint was a composite endpoint of infectious complications and mortality within 90 days. The main outcome was the absolute risk difference (95% CI) in the primary endpoint, adjusted for age and severity of appendicitis, with a non-inferiority margin of 7·5%. Outcome assessment was based on electronic patient records and a telephone consultation 90 days after appendicectomy. Efficacy was analysed in the intention-to-treat and per-protocol populations. Safety outcomes were analysed in the intention-to-treat population. This trial was registered with the Netherlands Trial Register, NL5946. Findings: Between April 12, 2017, and June 3, 2021, 13 267 patients were screened and 1066 were randomly assigned, 533 to each group. 31 were excluded from intention-to-treat analysis of the 2-day group and 30 from the 5-day group owing to errors in recruitment or consent. Appendicectomy was done laparoscopically in 955 (95%) of 1005 patients. The telephone follow-up was completed in 664 (66%) of 1005 patients. The primary endpoint occurred in 51 (10%) of 502 patients analysed in the 2-day group and 41 (8%) of 503 patients analysed in the 5-day group (adjusted absolute risk difference 2·0%, 95% CI −1·6 to 5·6). Rates of complications and re-interventions were similar between trial groups. Fewer patients had adverse effects of antibiotics in the 2-day group (45 [9%] of 502 patients) than in the 5-day group (112 [22%] of 503 patients; odds ratio [OR] 0·344, 95% CI 0·237 to 0·498). Re-admission to hospital was more frequent in the 2-day group (58 [12%] of 502 patients) than in the 5-day group (29 [6%] of 503 patients; OR 2·135, 1·342 to 3·396). There were no treatment-related deaths. Interpretation: 2 days of postoperative intravenous antibiotics for complex appendicitis is non-inferior to 5 days in terms of infectious complications and mortality within 90 days, based on a non-inferiority margin of 7·5%. These findings apply to laparoscopic appendicectomy conducted in a well resourced health-care setting. Adopting this strategy will reduce adverse effects of antibiotics and length of hospital stay. Funding: The Netherlands Organization for Health Research and Development.</p

Postoperative antibiotics and time to reach discharge criteria after appendectomy for complex appendicitis

IntroductionPostoperative antibiotic treatment is indicated for 3 - 5 days following appendectomy for complex appendicitis. However, meeting discharge criteria may allow for safe discontinuation of antibiotics and discharge. This study assessed the association between time to reach discharge criteria and duration of postoperative antibiotic use and length of stay. MethodsThis is a multicenter retrospective cohort study including patients who underwent appendectomy for complex appendicitis and received postoperative antibiotics for >24 hours. Main outcome measures were time to reach discharge criteria, duration of postoperative antibiotic use, length of hospital stay and postoperative infectious complications. Discharge criteria were defined as absence of fever (temperatur

Video-based tools for surgical quality assessment of technical skills in laparoscopic procedures: a systematic review

Background: Quality of surgery has substantial impact on both short- and long-term clinical outcomes. This stresses the need for objective surgical quality assessment (SQA) for education, clinical practice and research purposes. The aim of this systematic review was to provide a comprehensive overview of all video-based objective SQA tools in laparoscopic procedures and their validity to objectively assess surgical performance. Methods: PubMed, Embase.com and Web of Science were systematically searched by two reviewers to identify all studies focusing on video-based SQA tools of technical skills in laparoscopic surgery performed in a clinical setting. Evidence on validity was evaluated using a modified validation scoring system. Results: Fifty-five studies with a total of 41 video-based SQA tools were identified. These tools were used in 9 different fields of laparoscopic surgery and were divided into 4 categories: the global assessment scale (GAS), the error-based assessment scale (EBAS), the procedure-specific assessment tool (PSAT) and artificial intelligence (AI). The number of studies focusing on these four categories were 21, 6, 31 and 3, respectively. Twelve studies validated the SQA tool with clinical outcomes. In 11 of those studies, a positive association between surgical quality and clinical outcomes was found. Conclusion: This systematic review included a total of 41 unique video-based SQA tools to assess surgical technical skills in various domains of laparoscopic surgery. This study suggests that validated SQA tools enable objective assessment of surgical performance with relevance for clinical outcomes, which can be used for training, research and quality improvement programs

Surgery versus conservative management for recurrent and ongoing left-sided diverticulitis (DIRECT trial) : an open-label, multicentre, randomised controlled trial

Background Patients with recurrent or persisting complaints after an episode of left-sided diverticulitis are managed with either conservative measures or elective sigmoidectomy. To date, there are no data from randomised trials. We aimed to establish which treatment leads to a better quality of life for patients with diverticulitis. Methods We did an open-label, multicentre, randomised controlled trial (DIRECT trial) in 24 teaching and two academic hospitals in the Netherlands. Patients aged 18–75 years presenting with either recurrent (three or more presentations with clinical signs of acute diverticulitis within 2 years) or persistent abdominal complaints (ongoing lower left abdominal pain or persistent change in bowel habits for ≥3 months) after an episode of left-sided diverticulitis, confirmed by CT, ultrasound, or endoscopy, were included. Patients were excluded if they had previous elective or emergency surgery for acute sigmoid diverticulitis, an absolute operation indication, suspicion of a colorectal malignancy, with a preoperative or postoperative risk greater than III (on the American Society of Anesthesiologists classification), or were unable to complete questionnaire or follow-up. Patients were randomly assigned (3:3) to receive conservative management or elective (laparoscopic) sigmoidectomy using a digital randomisation system, stratified by type of disease and centre, with a block size of six. Patients, physicians, and researchers were not masked to treatment allocation. Our primary endpoint was health-related quality of life, measured by the Gastrointestinal Quality of Life Index (GIQLI) at 6 months after inclusion or surgery, depending on randomisation group. This trial is registered with trialregister.nl, number NTR1478, and is closed for inclusion. Findings Between July 1, 2010, and April 1, 2014, we randomly assigned 109 patients to receive surgical treatment (resection; n=53) or conservative management (n=56), after which the Data Safety and Monitoring Board prematurely terminated the trial because of increasing difficulties in recruitment. 47 (89%) of 53 patients received surgical treatment and 43 (77%) of 56 patients received conservative management. The GIQLI score at 6 months' follow-up was significantly higher in patients randomly assigned to receive surgical treatment (mean 114·4 [SD 22·3]) than conservative management (100·4 [22·7]; mean difference 14·2, 95% CI 7·2–21·1,

Surgery versus conservative management for recurrent and ongoing left-sided diverticulitis (DIRECT trial): an open-label, multicentre, randomised controlled trial

Patients with recurrent or persisting complaints after an episode of left-sided diverticulitis are managed with either conservative measures or elective sigmoidectomy. To date, there are no data from randomised trials. We aimed to establish which treatment leads to a better quality of life for patients with diverticulitis. We did an open-label, multicentre, randomised controlled trial (DIRECT trial) in 24 teaching and two academic hospitals in the Netherlands. Patients aged 18-75 years presenting with either recurrent (three or more presentations with clinical signs of acute diverticulitis within 2 years) or persistent abdominal complaints (ongoing lower left abdominal pain or persistent change in bowel habits for ≥3 months) after an episode of left-sided diverticulitis, confirmed by CT, ultrasound, or endoscopy, were included. Patients were excluded if they had previous elective or emergency surgery for acute sigmoid diverticulitis, an absolute operation indication, suspicion of a colorectal malignancy, with a preoperative or postoperative risk greater than III (on the American Society of Anesthesiologists classification), or were unable to complete questionnaire or follow-up. Patients were randomly assigned (3:3) to receive conservative management or elective (laparoscopic) sigmoidectomy using a digital randomisation system, stratified by type of disease and centre, with a block size of six. Patients, physicians, and researchers were not masked to treatment allocation. Our primary endpoint was health-related quality of life, measured by the Gastrointestinal Quality of Life Index (GIQLI) at 6 months after inclusion or surgery, depending on randomisation group. This trial is registered with trialregister.nl, number NTR1478, and is closed for inclusion. Between July 1, 2010, and April 1, 2014, we randomly assigned 109 patients to receive surgical treatment (resection; n=53) or conservative management (n=56), after which the Data Safety and Monitoring Board prematurely terminated the trial because of increasing difficulties in recruitment. 47 (89%) of 53 patients received surgical treatment and 43 (77%) of 56 patients received conservative management. The GIQLI score at 6 months' follow-up was significantly higher in patients randomly assigned to receive surgical treatment (mean 114·4 [SD 22·3]) than conservative management (100·4 [22·7]; mean difference 14·2, 95% CI 7·2-21·1, p <0·0001). 43 (38%) of 109 patients had a severe adverse event in the first 6 months after treatment (18 [34%] of 53 patients in the surgical treatment group vs 23 [40%] of 57 patients in the conservative treatment group). Seven (15%) patients who received surgical treatment developed anastomotic leakage. Of the 56 patients assigned to be treated conservatively, 13 (23%) ultimately underwent elective resection due to ongoing abdominal complaints, with no anastomotic leakage. We recorded no patient deaths. Elective sigmoidectomy, despite its inherent risk of complications, results in better quality of life than conservative management in patients with recurrent and persisting abdominal complaints after an episode of diverticulitis. Netherlands Organisation for Health Research and Developmen

Multicenter cohort study on the presentation and treatment of acute appendicitis during the COVID-19 pandemic

Purpose: Current studies have demonstrated conflicting results regarding surgical care for acute appendicitis during the COVID-19 pandemic. This study aimed to assess trends in diagnosis as well as treatment of acute appendicitis in the Netherlands during the first and second COVID-19 infection wave. Methods: All consecutive patients that had an appendectomy for acute appendicitis in nine hospitals from January 2019 to December 2020 were included. The primary outcome was the number of appendectomies for acute appendicitis. Secondary outcomes included time between onset of symptoms and hospital admission, proportion of complex appendicitis, postoperative length of stay and postoperative infectious complications. Outcomes were compared between the pre-COVID group and COVID group. Results: A total of 4401 patients were included. The mean weekly rate of appendectomies during the COVID period was 44.0, compared to 40.9 in the pre-COVID period. The proportion of patients with complex appendicitis and mean postoperative length of stay in days were similar in the pre-COVID and COVID group (respectively 35.5% vs 36.8%, p = 0.36 and 2.0 ± 2.2 vs 2.0 ± 2.6, p = 0.93). There were no differences in postoperative infectious complications. A computed tomography scan was used more frequently as a diagnostic tool after the onset of COVID-19 compared to pre-COVID (13.8% vs 9.8%, p < 0.001, respectively). Conclusion: No differences were observed in number of appendectomies, proportion of complex appendicitis, postoperative length of stay or postoperative infectious complications before and during the COVID-19 pandemic. A CT scan was used more frequently during the COVID-19 pandemic

Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial

Abstract Background Acute appendicitis is one of the most common indications for emergency surgery. In patients with a complex appendicitis, prolonged antibiotic prophylaxis is recommended after appendectomy. There is no consensus regarding the optimum duration of antibiotics. Guidelines propose 3 to 7 days of treatment, but shorter courses may be as effective in the prevention of infectious complications. At the same time, the global issue of increasing antimicrobial resistance urges for optimization of antibiotic strategies. The aim of this study is to determine whether a short course (48 h) of postoperative antibiotics is non-inferior to current standard practice of 5 days. Methods Patients of 8 years and older undergoing appendectomy for acute complex appendicitis – defined as a gangrenous and/or perforated appendicitis or appendicitis in presence of an abscess – are eligible for inclusion. Immunocompromised or pregnant patients are excluded, as well as patients with a contraindication to the study antibiotics. In total, 1066 patients will be randomly allocated in a 1:1 ratio to the experimental treatment arm (48 h of postoperative intravenously administered (IV) antibiotics) or the control arm (5 days of postoperative IV antibiotics). After discharge from the hospital, patients participate in a productivity-cost-questionnaire at 4 weeks and a standardized telephone follow-up at 90 days after appendectomy. The primary outcome is a composite endpoint of infectious complications, including intra-abdominal abscess (IAA) and surgical site infection (SSI), and mortality within 90 days after appendectomy. Secondary outcomes include IAA, SSI, restart of antibiotics, length of hospital stay (LOS), reoperation, percutaneous drainage, readmission rate, and cost-effectiveness. The non-inferiority margin for the difference in the primary endpoint rate is set at 7.5% (one-sided test at ɑ 0.025). Both per-protocol and intention-to-treat analyses will be performed. Discussion This trial will provide evidence on whether 48 h of postoperative antibiotics is non-inferior to a standard course of 5 days of antibiotics. If non-inferiority is established, longer intravenous administration following appendectomy for complex appendicitis can be abandoned, and guidelines need to be adjusted accordingly. Trial registration Dutch Trial Register, NTR6128. Registered on 20 December 2016