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Importance: Surgical site infections (SSIs)-especially anastomotic dehiscence-are major contributors to morbidity and mortality after rectal resection. The role of mechanical and oral antibiotics bowel preparation (MOABP) in preventing complications of rectal resection is currently disputed., Objective: To assess whether MOABP reduces overall complications and SSIs after elective rectal resection compared with mechanical bowel preparation (MBP) plus placebo., Design, Setting, and Participants: This multicenter, double-blind, placebo-controlled randomized clinical trial was conducted at 3 university hospitals in Finland between March 18, 2020, and October 10, 2022. Patients aged 18 years and older undergoing elective resection with primary anastomosis of a rectal tumor 15 cm or less from the anal verge on magnetic resonance imaging were eligible for inclusion. Outcomes were analyzed using a modified intention-to-treat principle, which included all patients who were randomly allocated to and underwent elective rectal resection with an anastomosis., Interventions: Patients were stratified according to tumor distance from the anal verge and neoadjuvant treatment given and randomized in a 1:1 ratio to receive MOABP with an oral regimen of neomycin and metronidazole (n = 277) or MBP plus matching placebo tablets (n = 288). All study medications were taken the day before surgery, and all patients received intravenous antibiotics approximately 30 minutes before surgery., Main Outcomes and Measures: The primary outcome was overall cumulative postoperative complications measured using the Comprehensive Complication Index. Key secondary outcomes were SSI and anastomotic dehiscence within 30 days after surgery., Results: In all, 565 patients were included in the analysis, with 288 in the MBP plus placebo group (median [IQR] age, 69 [62-74] years; 190 males [66.0%]) and 277 in the MOABP group (median [IQR] age, 70 [62-75] years; 158 males [57.0%]). Patients in the MOABP group experienced fewer overall postoperative complications (median [IQR] Comprehensive Complication Index, 0 [0-8.66] vs 8.66 [0-20.92]; Wilcoxon effect size, 0.146; P < .001), fewer SSIs (23 patients [8.3%] vs 48 patients [16.7%]; odds ratio, 0.45 [95% CI, 0.27-0.77]), and fewer anastomotic dehiscences (16 patients [5.8%] vs 39 patients [13.5%]; odds ratio, 0.39 [95% CI, 0.21-0.72]) compared with patients in the MBP plus placebo group., Conclusions and Relevance: Findings of this randomized clinical trial indicate that MOABP reduced overall postoperative complications as well as rates of SSIs and anastomotic dehiscences in patients undergoing elective rectal resection compared with MBP plus placebo. Based on these findings, MOABP should be considered as standard treatment in patients undergoing elective rectal resection., Trial Registration: ClinicalTrials.gov Identifier: NCT04281667.

Importance: Both elective sigmoid resection and conservative treatment are options for patients with recurrent, complicated, or persistent painful diverticulitis; understanding outcomes following each can help inform decision-making., Objective: To compare outcomes of elective sigmoid resection and conservative treatment for patients with recurrent, complicated, or persistent painful diverticulitis at 2-year follow-up., Design, Setting, and Participants: This multicenter parallel open-label individually randomized clinical trial comparing elective sigmoid resection to conservative treatment in patients with recurrent, complicated, or persistent painful diverticulitis was carried out in 5 Finnish hospitals between September 2014 and October 2018. Follow-up up to 2 years is reported. Of 85 patients randomized and included, 75 and 70 were available for QOL outcomes at 1 year and 2 years, respectively, and 79 and 78 were available for the recurrence outcome at 1 year and 2 years, respectively. The present analysis was conducted from September 2015 to June 2022., Interventions: Laparoscopic elective sigmoid resection vs conservative treatment (patient education and fiber supplementation)., Main Outcomes and Measures: Prespecified secondary outcomes included Gastrointestinal Quality of Life Index (GIQLI) score, complications, and recurrences within 2 years., Results: Ninety patients (28 male [31%]; mean [SD] age, 54.11 [11.9] years and 62 female [69%]; mean [SD] age, 57.13 [7.6] years) were randomized either to elective sigmoid resection or conservative treatment. After exclusions, 41 patients in the surgery group and 44 in the conservative group were included in the intention-to-treat analyses. Eight patients (18%) in the conservative treatment group underwent sigmoid resection within 2 years. The mean GIQLI score at 1 year was 9.51 points higher in the surgery group compared to the conservative group (mean [SD], 118.54 [17.95] vs 109.03 [19.32]; 95% CI, 0.83-18.18; P = .03), while the mean GIQLI score at 2 years was similar between the groups. Within 2 years, 25 of 41 patients in the conservative group (61%) had recurrent diverticulitis compared to 4 of 37 patients in the surgery group (11%). Four of 41 patients in the surgery group (10%) and 2 of 44 in the conservative group (5%) had major postoperative complications within 2 years. In per-protocol analyses, the mean (SD) GIQLI score was higher in the surgery group compared to the conservative treatment group by 11.27 points at 12 months (119.42 [17.98] vs 108.15 [19.28]; 95% CI, 2.24-20.29; P = .02) and 10.43 points at 24 months (117.24 [15.51] vs 106.82 [18.94]; 95% CI, 1.52-19.33; P = .02)., Conclusions and Relevance: In this randomized clinical trial, elective sigmoid resection was effective in preventing recurrent diverticulitis and improved quality of life over conservative treatment within 2 years., Trial Registration: ClinicalTrials.gov Identifier: NCT02174926.

Importance: Diverticulitis has a tendency to recur and affect quality of life., Objective: To assess whether sigmoid resection is superior to conservative treatment in improving quality of life of patients with recurrent, complicated, or persistent painful diverticulitis., Design, Setting, and Participants: This open-label randomized clinical trial assessed for eligibility 128 patients with recurrent, complicated, or persistent painful diverticulitis in 6 Finnish hospitals from September 29, 2014, to October 10, 2018. Exclusion criteria included age younger than 18 years or older than 75 years; lack of (virtual) colonoscopy or sigmoidoscopy data within 2 years, or presence of cancer, contraindication to laparoscopy, or fistula. Outcomes were assessed using intention-to-treat analysis. A prespecified interim analysis was undertaken when 66 patients had been randomized and their 6-month follow-up was assessable. Data were analyzed from June 2018 to May 2020., Interventions: Laparoscopic sigmoid resection or conservative treatment., Main Outcomes and Measures: The primary outcome was difference in Gastrointestinal Quality of Life Index (GIQLI) score between randomization and 6 months., Results: Of 128 patients assessed for eligibility, 90 were randomized (28 male [31%]; mean [SD] age, 54.11 [11.9] years; 62 female [69%]; mean [SD] age, 57.13 [7.6] years). A total of 72 patients were included in analyses for the primary outcome (37 in the surgery group and 35 in the conservative treatment group), and 85 were included in analyses for clinical outcomes (41 in the surgery group and 44 in the conservative treatment group). The difference between GIQLI score at randomization and 6 months was a mean of 11.96 points higher in the surgery group than in the conservative treatment group (mean [SD] of 11.76 [15.89] points vs -0.2 [19.07] points; difference, 11.96; 95% CI, 3.72-20.19; P = .005). Four patients (10%) in the surgery group and no patients in the conservative treatment group experienced major complications (Clavien-Dindo grade III or higher). There were 2 patients (5%) in the surgery group and 12 patients (31%) in the conservative treatment group who had new episodes of diverticulitis within 6 months., Conclusions and Relevance: In this randomized clinical trial, elective laparoscopic sigmoid resection improved quality of life in patients with recurrent, complicated, or persistent painful diverticulitis but carried a 10% risk of major complications., Trial Registration: ClinicalTrials.gov Identifier: NCT02174926.

Importance: Both hydrocortisone and pasireotide have been shown in randomized clinical trials to be effective in reducing postoperative complications of pancreatic surgery, but to date no randomized clinical trial has evaluated the effectiveness of pasireotide compared with hydrocortisone., Objective: To assess the noninferiority of hydrocortisone compared with pasireotide in reducing complications after partial pancreatectomy., Design, Setting, and Participants: A noninferiority, parallel-group, individually randomized clinical trial was conducted at a single academic center between May 19, 2016, and December 17, 2018. Outcome collectors and analyzers were blinded. A total of 281 patients undergoing partial pancreatectomy were assessed for inclusion. Patients younger than 18 years, those allergic to hydrocortisone or pasireotide, patients undergoing pancreaticoduodenectomy with hard pancreas or dilated pancreatic duct, and patients not eventually undergoing partial pancreatectomy were excluded. Modified intention-to-treat analysis was used in determination of the results., Interventions: Treatment included pasireotide, 900 μg, subcutaneously twice a day for 7 days or hydrocortisone, 100 mg, intravenously 3 times a day for 3 days., Main Outcomes and Measures: The primary outcome was the Comprehensive Complication Index (CCI) score within 30 days. The noninferiority limit was set to 9 CCI points., Results: Of the 281 patients (mean [SD] age, 63.8 years) assessed for eligibility, 168 patients (mean [SD] age, 63.6 years) were randomized and 126 were included in the modified intention-to-treat analyses. Sixty-three patients received pasireotide (35 men [56%]; median [interquartile range] age, 64 [56-70] years) and 63 patients received hydrocortisone (25 men [40%]; median [interquartile range] age, 67 [56-73] years). The mean (SD) CCI score was 23.94 (17.06) in the pasireotide group and 30.11 (20.47) in the hydrocortisone group (mean difference, -6.16; 2-sided 90% CI, -11.73 to -0.60), indicating that hydrocortisone was not noninferior. Postoperative pancreatic fistula was detected in 34 patients (54%) in the pasireotide group and 39 patients (62%) in the hydrocortisone group (odds ratio, 1.39; 95% CI, 0.68-2.82; P = .37). One patient in the pasireotide group and 2 patients in the hydrocortisone group died within 30 days. In subgroup analyses of patients undergoing distal pancreatectomy, the CCI score was a mean of 10.3 points lower (mean [SD], 16.03 [11.94] vs 26.28 [21.76]; 2-sided 95% CI, -19.34 to -2.12; P = .03) and postoperative pancreatic fistula rate was lower (37% vs 67%; P = .02) in the pasireotide group compared with the hydrocortisone group., Conclusions and Relevance: In this study, hydrocortisone was not noninferior compared with pasireotide in patients undergoing partial pancreatectomy. Pasireotide may be more effective than hydrocortisone in patients undergoing distal pancreatectomy., Trial Registration: ClinicalTrials.gov identifier: NCT02775227; EudraCT identifier: 2016-000212-16.