Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background: Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods: The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results: A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion: Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)

The effect of preemptive use of pregabalin on postoperative morphine consumption and analgesia levels after laparoscopic colorectal surgery: a controlled randomized trial

Purpose: In order to reduce postoperative opioid administration and pain levels in patients submitted to laparoscopic colectomy, we assessed the efficacy of preemptive use of pregabalin (PG), as part of a multimodal analgesia scheme, in a randomized controlled trial setting. Methods: Overall, fifty adult patients scheduled for elective laparoscopic colectomy were included and randomized in our trial. In the experimental group, 23 patients received preoperatively 2 doses of 150 mg PG per os, whereas the control group consisted of 27 cases, where a matching to PG placebo was administered at the same scheme. The two groups had identical analgesia and anesthesia regimens otherwise. Our study endpoints included postoperative morphine consumption, postoperative pain, and complication rates. Results: Patients in the PG group displayed a significantly reduced morphine consumption at 8 h, 24 h, and 48 h postoperatively. The two groups were comparable in terms of postoperative pain (rest and movement assessment) and side effects. Conclusions: The preoperative addition of PG resulted in a significant reduction of the postoperative opioid consumption in patients undergoing laparoscopic colectomy. However, an association with the postoperative pain scores was not identified. © 2019, Springer-Verlag GmbH Germany, part of Springer Nature

Determination of Factors Related to the Reversal and Perioperative Outcomes of Defunctioning Ileostomies in Patients Undergoing Rectal Cancer Surgery: A Regression Analysis Model

Purpose: Defunctioning ileostomies are often performed during rectal cancer surgery. However, stomas are sometimes associated with complications, while 20–30% of them are never reversed. Additionally, ileostomy closure can have associated morbidity, with rates as high as 45%, with the respective literature evidence being scarce and conflicting. Thus, we evaluated the stoma reversal outcomes and the risk factors for non-closure after rectal cancer surgery. Methods: This is a retrospective analysis of a prospectively collected database of all patients who had a defunctioning ileostomy at the time of resection for rectal cancer. All operations were performed by the same surgical team. A multivariable regression model was implemented. Results: In this study, 129 patients (male: 68.2%, female: 31.8%) were included. Ileostomy formation was associated with a total of 31% complication rate. Eventually 73.6% of the stomas were reversed at a mean time to closure of 26.6 weeks, with a morbidity of 13.7%. Non-reversal of ileostomy was correlated with neoadjuvant CRT (OR: 0.093, 95% CI: 0.012–0.735), anastomotic leakage (OR: 0.107, 95% CI: 0.019–0.610), and lymph node yield (OR: 0.946, 95% CI: 0.897–0.998). Time to reversal was affected by the N status, the LNR, the need for adjuvant chemotherapy, and the histologic grade. Conclusion: In patients with rectal cancer resections, defunctioning stoma closure rate and time to closure were associated with several perioperative and pathological outcomes. © 2022, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature