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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKepler University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

< 18 years

Pregnancy

BMI > 55kg/m2

Current colorectal carcinoma in the left-sided colon

Trial design

Treatments tested in this trial

  • Sigmoid resection

Treatment groups

136 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Kepler University Hospital

Lead sponsor

Krankenhaus Barmherzige Schwestern Linz

Collaborator

Elisabethinen Hospital

Collaborator

Universitätsmedizin Mannheim

Collaborator