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

NCT03994978 | Completed

• 1 other identifier: FRESCO Trial
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diverticulitis of Sigmoid

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in gastrointestinal quality of Life: gastrointestinal quality of life score" (GIQLI score)

  change from baseline to 12 months after intervention

• Change in erectile function

  change from baseline to 12 months after intervention

Study Arms (2)

Surgical group

Patients with uncomplicated recurrent diverticulitis undergoing elective sigmoid resection

Procedure: elective sigmoidectomy

Conservative group

Patients with uncomplicated recurrent diverticulitis with conservative treatment

Interventions

elective sigmoidectomy PROCEDURE

elective sigmoidectomy

Surgical group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

St. Claraspital Basel

Basel, Switzerland

Location

Study Officials

• Bettina Wölnerhanssen, MD

  St. Clara Research Ltd.

  STUDY CHAIR

• Daniel Steinemann, MD

  Clarunis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 21, 2019
• Study Start: July 8, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 27, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)