Laparoscopic lavage for Hinchey III perforated diverticulitis:factors for treatment failure in two randomized clinical trials

BACKGROUND: The Scandinavian Diverticulitis (SCANDIV) trial and the LOLA arm of the LADIES trial randomized patients with Hinchey III perforated diverticulitis to laparoscopic peritoneal lavage or sigmoid resection. The aim of this analysis was to identify risk factors for treatment failure in patients with Hinchey III perforated diverticulitis.METHODS: This was a post hoc analysis of the SCANDIV trial and LOLA arm. Treatment failure was defined as morbidity requiring general anaesthesia (Clavien-Dindo grade IIIb or higher) within 90 days. Age, sex, BMI, ASA fitness grade, smoking status, previous episodes of diverticulitis, previous abdominal surgery, time to surgery, and surgical competence were all tested in univariable and multivariable logistic regression analyses using an interaction variable.RESULTS: The pooled analysis included 222 patients randomized to laparoscopic lavage and primary resection (116 and 106 patients respectively). Univariable analysis found ASA grade to be associated with advanced morbidity in both groups, and the following factors in the laparoscopic lavage group: smoking, corticosteroid use, and BMI. Significant factors for laparoscopic lavage morbidity in multivariable analysis were smoking (OR 7.05, 95 per cent c.i. 2.07 to 23.98; P = 0.002) and corticosteroid use (OR 6.02, 1.54 to 23.51; P = 0.010).CONCLUSION: Active smoking status and corticosteroid use were risk factors for laparoscopic lavage treatment failure (advanced morbidity) in patients with perforated diverticulitis

Risk factors for recurrence and complications in acute uncomplicated diverticulitis : A retrospective cohort study

Introduction: Antibiotics for acute uncomplicated diverticulitis (AUD) have been questioned in several studies. Thus, it is of value to identify risk factors for recurrence and complications to identify the best strategy for treatment. The aim was to investigate risk factors for recurrence and complications within at least 1 year after hospitalization for AUD. Methods: This is a retrospective study, including patients hospitalized with AUD at Helsingborg Hospital and Skåne University Hospital in Sweden during January 1st, 2015–December 31st, 2017. The cohort was primarily collected via the in-patient registry. Patients with multiple registrations, acute complicated diverticulitis, ongoing antibiotics, other diagnoses, immunosuppression and non-CT-verified diagnosis were excluded. Follow-up was ≥1 year. SPSS was used for statistical analysis. Results: Out of 596 patients, 23% experienced recurrences and 3% experienced complications. Previous diverticulitis [OR 2.86 (CI 1.85–4.55) P < 0.001] and complications [OR 1.35 (CI 1.18–1.42) P < 0.001] were independent risk factors for recurrence. A higher Charlson morbidity index (CMI) [OR 1.27 (1.0–1.61) P = 0.04] and previous diverticulitis [OR 3.68 (1.24–10.9) P = 0.013] were associated with complications. 75% of the patients received antibiotics but this did not significantly improve outcomes. Conclusion: A history of previous diverticulitis or complications increases the risk for AUD recurrence. A higher CMI and a history of previous diverticulitis may be risk factors for complications but needs to be further assessed. Treatment with antibiotics does not appear to improve the outcome. Choice of treatment should therefore be individualized and based on risk factors for complications and recurrence

Acute uncomplicated diverticulitis managed without antibiotics – difficult to introduce a new treatment protocol but few complications

Objective: Routine antibiotic treatment of acute uncomplicated diverticulitis (AUD) has been shown ineffective. In this study, the adherence to a new treatment protocol for uncomplicated diverticulitis was evaluated and the incidence of complications in patients treated with and without antibiotics was investigated. Materials and methods: A retrospective study of in-patients diagnosed with AUD at Helsingborg Hospital, Sweden between 01 January 2013 and 06 January 2015 was performed. Antibiotics were routinely administrated until 01 May 2014. Thereafter, a new antibiotic-free treatment protocol for uncomplicated diverticulitis was introduced. All the patients were followed regarding complications for minimum one year. Results: A total of 50 patients were studied after the new protocol implementation and, 60% (n = 31) of the patients were treated without antibiotics. Specialists initiated antibiotic therapy significantly more often than registrars (p=.03). More patients in the antibiotic group had comorbidities (p=.03), apart from that, no significant differences in baseline characteristics were noted between treatment groups. Patients treated with antibiotics after introduction of the new protocol had significantly higher C-reactive protein than patients managed without antibiotics (median 117 mg/L vs. 70, p=.005). The hospital stay was shorter in the non-antibiotic group (three days vs. two days; p=.008). No significant differences in complications were observed. Conclusions: Protocol compliance was lower than expected, indicating that implementation of new treatment regimens is challenging. This study confirms that complications are rare in AUD treated without antibiotics. However, the selection of the sickest patients to the treatment with antibiotics limits the interpretation of the results

Management of acute uncomplicated diverticulitis without antibiotics: compliance and outcomes -a retrospective cohort study

MethodsRecent randomized control trials (RCTs) have confirmed that antibiotics in acute uncomplicated diverticulitis (AUD) neither accelerate recovery nor prevent complications or recurrences.A retrospective cohort study was conducted, including all consecutive AUD patients hospitalized 2015- 2018 at Helsingborg Hospital (HH) and Skåne University Hospital (SUS), Sweden. HH had implemented a non-antibiotic treatment protocol in 2014 while SUS had not. Main outcomes were proportion of patients treated with antibiotics, complications, recurrences, and adherence to routinely colon evaluation.ResultsA total of 583 AUD patients were enrolled, 388 at SUS and 195 at HH. The diagnosis was CT-verified in 320 (83%) vs. 186 (95%) patients respectively (p < 0.001). Forty-three (11%) and 94 (48%) of patients respectively did not receive antibiotics during hospitalization (p < 0.001). CRP was higher in the antibiotic group compared to the non-antibiotic group, both at admission and peak (90 mg/L vs 65 mg/L; p = 0.016) and (138 mg/L and 97 mg/L; p < 0.001). There were no significant differences in recurrences (22.0% vs. 22.6%; p = 0.87) and complications (2.5% vs. 2.9%; p = 0.77) between the antibiotic/non-antibiotic groups.ConclusionThe structured treatment protocol led to reduced antibiotic use and a higher standard of care in terms of CT-verification. Clinicians’ compliance to the treatment protocol and best clinical practice was poor and warrants further studies

Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis : Long-term Outcomes From the Scandinavian Diverticulitis (SCANDIV) Randomized Clinical Trial

Importance Perforated colonic diverticulitis usually requires surgical resection, with significant morbidity. Short-term results from randomized clinical trials have indicated that laparoscopic lavage is a feasible alternative to resection. However, it appears that no long-term results are available. Objective To compare long-term (5-year) outcomes of laparoscopic peritoneal lavage and primary resection as treatments of perforated purulent diverticulitis. Design, Setting, and Participants This international multicenter randomized clinical trial was conducted in 21 hospitals in Sweden and Norway, which enrolled patients between February 2010 and June 2014. Long-term follow-up was conducted between March 2018 and November 2019. Patients with symptoms of left-sided acute perforated diverticulitis, indicating urgent surgical need and computed tomography–verified free air, were eligible. Those available for trial intervention (Hinchey stages <IV) were included in the long-term follow-up. Interventions Patients were assigned to undergo laparoscopic peritoneal lavage or colon resection based on computer-generated, center-stratified block randomization. Main Outcomes and Measures The primary outcome was severe complications within 5 years. Secondary outcomes included mortality, secondary operations, recurrences, stomas, functional outcomes, and quality of life. Results Of 199 randomized patients, 101 were assigned to undergo laparoscopic peritoneal lavage and 98 were assigned to colon resection. At the time of surgery, perforated purulent diverticulitis was confirmed in 145 patients randomized to lavage (n = 74) and resection (n = 71). The median follow-up was 59 (interquartile range, 51-78; full range, 0-110) months, and 3 patients were lost to follow-up, leaving a final analysis of 73 patients who had had laparoscopic lavage (mean [SD] age, 66.4 [13] years; 39 men [53%]) and 69 who had received a resection (mean [SD] age, 63.5 [14] years; 36 men [52%]). Severe complications occurred in 36% (n = 26) in the laparoscopic lavage group and 35% (n = 24) in the resection group (P = .92). Overall mortality was 32% (n = 23) in the laparoscopic lavage group and 25% (n = 17) in the resection group (P = .36). The stoma prevalence was 8% (n = 4) in the laparoscopic lavage group vs 33% (n = 17; P = .002) in the resection group among patients who remained alive, and secondary operations, including stoma reversal, were performed in 36% (n = 26) vs 35% (n = 24; P = .92), respectively. Recurrence of diverticulitis was higher following laparoscopic lavage (21% [n = 15] vs 4% [n = 3]; P = .004). In the laparoscopic lavage group, 30% (n = 21) underwent a sigmoid resection. There were no significant differences in the EuroQoL-5D questionnaire or Cleveland Global Quality of Life scores between the groups. Conclusions and Relevance Long-term follow-up showed no differences in severe complications. Recurrence of diverticulitis after laparoscopic lavage was more common, often leading to sigmoid resection. This must be weighed against the lower stoma prevalence in this group. Shared decision-making considering both short-term and long-term consequences is encouraged

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 &lt; 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)