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)

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.

Study Overview

• Status: Completed
• Conditions: Diverticulitis of Sigmoid
• Intervention / Treatment: Procedure: elective sigmoidectomy

Detailed Description

The prevalence of diverticular disease of sigmoid in the Western has increased over the past century and our know-how of this disease and its management continues to evolve. International experts have tried to standardize the surgical approach to patients with recurrent episodes of sigmoid diverticulitis but, to date, no guidelines are universally recognized.The American Society of Colon and Rectal Surgeons (ASCRS) and the World Society of Emergency Surgery (WSES) recommend an individualized approach after recovery from uncomplicated acute diverticulitis to plan an elective sigmoid resection. The impact of ongoing disorders on quality of life (QoL) and not the number of previous episodes of diverticulitis should be the most determining factor. The German guideline by the Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie (DGAV) recommend an elective sigmoid resection after a careful risk/benefit assessment depending on the clinical presentation in the disease-free interval in patients with chronic relapsing diverticulitis.The Danish Surgical Society (DSS) is more restrained and mentions the unnecessary risk in terms of morbidity and mortality to the individual as well as costs to society in prophylactic resection of the sigmoid. Therefore, they recommend that elective surgery should be probably limited to symptomatic cases not amenable to conservative measures. Moreover, recent studies have demonstrated that the number of attacks of diverticulitis is not necessarily a prevailing factor in defining the suitability of surgery and the operation itself carries significant morbidity and mortality. The German guidelines describe also a persistence of the symptoms in patients who underwent sigmoid resection in 22-25%. An uncomplicated diverticulitis is generally considered a mild and self-limiting disease, performing a potentially harmful procedure in these patients does not seem justified. However, elective resection may be an appropriate solution for a more selective group of patients who suffer greatly from their disease. Many studies have consistently shown that 40-80% remain symptomatic after conservative treatment, leading to impaired health-related Quality of life (HRQoL) and increased costs.

• Study Type: Observational
• Enrollment (Actual): 252

Contacts and Locations

• Study Contact: Name: Bettina Wölnerhanssen, MD; Phone Number: 0041616858585; Email: bettina.woelnerhanssen@claraspital.ch

Study Locations

• Switzerland
  • Basel, Switzerland
    • St. Claraspital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with recurrent episodes of diverticulitis with indication of further treatment.The physician decides which therapy (conservative or surgical) will be carried out.

Description

Inclusion Criteria:

• 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 Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical group; Patients with uncomplicated recurrent diverticulitis undergoing elective sigmoid resection	Procedure: elective sigmoidectomy; elective sigmoidectomy
Conservative group; Patients with uncomplicated recurrent diverticulitis with conservative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in grade of fecal incontinence incontinence score	Fecal incontinence measured by total "Vaizey-Wexner incontinence score" ranging from 0 to 24; lower values represent better outcome	change from baseline to 12 months after intervention
Change in grade of constipation	Constipation measured by total "Cleveland constipation score" ranging from 0 to 30; lower values represent better outcome	change from baseline to 12 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gastrointestinal quality of Life: gastrointestinal quality of life score" (GIQLI score)	Gastrointestinal quality of life measured by total "gastrointestinal quality of life score" (GIQLI score) ranging from 0-144; higher values represent better outcome	change from baseline to 12 months after intervention
Change in erectile function	Erectile function measured by total "international index of erectile function" (IIEF-5-score) ranging from 5 to 25; higher values represent better outcome	change from baseline to 12 months after intervention

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Chair: Bettina Wölnerhanssen, MD, St. Clara Research Ltd.; Principal Investigator: Daniel Steinemann, MD, Clarunis

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 27, 2022

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 2, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Diverticulitis
• Other Study ID Numbers: FRESCO Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No