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Does elective sigmoid resection improve the quality of life in patients with recurrent diverticulitis, complicated diverticulitis, and/or chronic pain after an episode of diverticulitis?
In this randomized clinical trial that included 85 adults, the Gastrointestinal Quality of Life Index (GIQLI) score improved 11.8 points in patients randomized to sigmoid resection and 0.2 points in patients randomized to conservative treatment between baseline and 6 months, a statistically and clinically significant difference. Among 41 patients randomized to sigmoid resection, 4 (10%) experienced major complications.
Sigmoid resection improved quality of life in patients with recurrent, complicated, or persistent painful diverticulitis but was associated with a small but significant risk of major complications.
Diverticulitis has a tendency to recur and affect quality of life.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT02174926.
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Accepted for Publication: August 1, 2020.
Published Online: November 18, 2020. doi:10.1001/jamasurg.2020.5151
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2020 Santos A et al. JAMA Surgery.
Corresponding Author: Ville Sallinen, MD, PhD, Transplantation and Liver Surgery, University of Helsinki, Helsinki University Hospital, Haartmaninkatu 4, Helsinki, Finland 00029 (email@example.com).
Author Contributions: Drs Santos and Sallinen had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Santos, Mentula, Scheinin, Sallinen.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Santos, Pinta, Sallinen.
Critical revision of the manuscript for important intellectual content: Santos, Mentula, Ismail, Rautio, Juusela, Lähdesmäki, Scheinin, Sallinen.
Statistical analysis: Santos, Sallinen.
Obtained funding: Santos, Sallinen.
Administrative, technical, or material support: Santos, Mentula, Pinta, Rautio, Juusela, Lähdesmäki, Scheinin, Sallinen.
Supervision: Mentula, Scheinin, Sallinen.
Conflict of Interest Disclosures: Dr Santos reports grants from The Finnish Medical Foundation during the conduct of the study. Dr Sallinen reports grants from Vatsatautien Tutkimussäätiö Foundation, Mary and Georg Ehrnrooth’s Foundation, Martti I. Turunen Foundation, and Helsinki University Hospital research funds during the conduct of the study as well as grants from Academy of Finland, Finnish Cancer Foundation (Syöpäsäätiö), and Finnish Gastroenterological Society and personal fees from Finnish Gastroenterological Society, City of Vantaa, and University of Helsinki outside the submitted work. Dr Scheinin reports personal fees from Johnson & Johnson outside the submitted work. No other disclosures were reported.
Funding/Support: The study was funded by Vatsatautien Tutkimussäätiö Foundation, Mary and Georg Ehrnrooth’s Foundation, Martti I. Turunen Foundation, The Finnish Medical Foundation, and Helsinki University Hospital research funds.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
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