Quality of Life in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis

Recruiting now · Not applicable

Conditions studied: Diverticulitis of Sigmoid

In brief

Patients presenting in hospital with symptoms of acute diverticulitis. Acute inflammation of the left-sided colon is confirmed with CT scan or ultrasound in experienced centers and diagnosis is defined according to the "Classification of Diverticular Disease (CDD)". CDD Type 2a, 2b and 3b will be included and then randomized in two groups. Group A will get an early left hemicolectomy 7 to 10 days after admission and initial antibiotic therapy and/or drainage of the abscess. Group B is designated for an elective resection 6 to 8 weeks after dismissal at the earliest and initial conservative treatment and/or after drainage of the abscess. Six weeks after the operation patients of Group A will be asked for their present quality of life with a standardized scoring system (Gastrointestinal Quality of Life Index = GIQLI; Short-form 36 Score = SF-36 Score; Low anterior resection syndrome = LARS Score). Group B (elective resection) will be asked at their readmission prior to elective surgery is done. This survey package will be repeated again 6 to 8 weeks later in both groups. Primary endpoints will be the two GIQLI at the said examination times. Secondary endpoints will be SF-36 score, LARS-score, GIQLI-Domains, anastomosis insufficiency and other complications, mortality and length of hospital stay. Comparisons between the groups are made at the said examination times but also 6-8 weeks after the operation.

Key facts

Study ID

NCT05942833

Run by

Kepler University Hospital

People needed

136

Starts

2023-01-16

Expected to finish

2027-07-01

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent to participate in the study
• CDD Type 2a, 2b: acute complicated left-sided diverticulitis
• CDD Type 3b: relapsing diverticulitis without complications (>2 episodes within 2 years)
• Acute presentation
• Inflammation located in the left-sided colon
• Inflammation is CT proven or ultrasound confirmed from experienced radiologists

You may not qualify if…

• < 18 years
• Pregnancy
• BMI > 55kg/m2
• Current colorectal carcinoma in the left-sided colon
• Oral and/or intravenous corticosteroid
• Ongoing chemotherapy
• Status post left hemicolectomy
• Patients who cannot take care of themselves at home or are unable to follow instructions
• Patients who are not fit for surgery (anesthesia, expert knowledge from specialists) and will not benefit from surgery

Where it is running

• Ordensklinikum Elisabethinen Linz — Linz, Austria, Austria (enrolling)
• Krankenhaus Barmherzige Schwestern Linz — Linz, Upper Austria, Austria (enrolling)
• Kepler University Hospital — Linz, Upper Austria, Austria (enrolling)
• Universitätsklinikum Mannheim — Mannheim, Mannheim, Germany

Full record on ClinicalTrials.gov

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