Diverticulitis Recurrences or Continuing symptoms : Operative versus Conservative Treatment, A MULTICENTER RANDOMISED CLINICAL TRIA

Completed

• Conditions: diverticulitis; inflammation of outpouchings in the colonic wall; 10013535

• Registration Number: NL-OMON39335
• Lead Sponsor: Meander Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 214

Inclusion Criteria

- Age 18-75 years.
- A well documented (CT-scan, sonography or endoscopy) previous episode of diverticulitis.
- Patients presenting with either persisting abdominal complaints and/or frequently recurring diverticulitis after an episode of diverticulitis.
Persisting abdominal complaints may include patients with:
- continuing lower left abdominal pain AND/OR persistent change in bowel habits AND/OR persistent blood loss.
- Symptoms must exist longer than 3 months after a previous episode of diverticulitis.
- Symptoms must be accompanied by changes in the colonic wall on a recent CT-scan,
sonography or endoscopy.
Frequently recurring diverticulitis is defined as:
- A total of three or more in-hospital presentations for an episode of diverticulitis within 2
years. As described previously, (at least) one episode must be well documented (CT-scan,
sonography or endoscopy).
- A minimal interval of 3 months between the episodes is mandatory.
- ASA I-III

Exclusion Criteria

- Patients with elective or emergency surgery for acute diverticulitis in the past.
- Patients with an absolute operation indication (perforation with purulent/fecal peritonitis, symptomatic bowel stenosis or fistula).
- Patients with colorectal malignancies.
- Patients with a psychiatric disease or other conditions making them incapable of filling out the questionnaires or completing the objective follow up tests.
- Patients in ASA class III who are at high risk for per- and postoperative complications due o severe co-morbidity as regarded by the surgeon and/or the patients specialists

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Quality of life measured by the Gastro-intestinal Quality of Life Index,<br /><br>Shortform-36, EuroQol-5D, ROME III vragenlijst and VAS. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Mortality<br /><br>- Morbidity<br /><br>- Recurrence rate<br /><br>- Total in-hospital costs (including that of subsequents episodes), as well as<br /><br>costs related to sick leave from paid work and health care consumption. </p><br>