RecruitingNCT03994978

Bowel Function/QoL After Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis

Preoperative vs. Postoperative Bowel Function and Quality of Life in Patients Undergoing Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis (FRESCO-Trial)

Sponsor

University Hospital, Basel, Switzerland

Enrollment

252 participants

Start Date

Jul 8, 2019

Study Type

OBSERVATIONAL

Conditions

Diverticulitis of Sigmoid

Summary

The decision to perform a surgical intervention or not after recovery from repeated uncomplicated episodes of acute diverticulitis remains controversial and the literature shows different conflicting approaches based on low-quality evidence.The goal of this trial is to achieve a better understanding of the impact of surgery on bowel function and QoL in patients with recurrent uncomplicated sigmoid diverticulitis in order to develop treatment guidelines.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Patients with recurrent uncomplicated diverticulitis and surgical indication for sigmoid resection
Patients with recurrent uncomplicated diverticulitis and non-surgical indication for conservative management
Confirmation of at least one episode of acute uncomplicated diverticulitis in computed tomography

Exclusion Criteria8

Patients aged under 18.
Patients unable to understand an informed consent.
Patients with chronic pain disorder.
Patients with sigmoid fistulas
Emergency operations.
Pregnant women or lactation.
Patients with other severe gastrointestinal diseases, such as inflammatory bowel diseases (IBD), carcinoma or immunologic disorders.
Patients unable to perform surgery or high-risk patients according to the American Society of Anesthesiology (ASA 4 grade or higher)