Actively Recruiting
DATE Trial: Outcomes and Quality of Life in Patients With Early Versus Elective Resection in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis
Led by Kepler University Hospital · Updated on 2026-03-18
136
Participants Needed
4
Research Sites
30 weeks
Total Duration
On this page
Sponsors
K
Kepler University Hospital
Lead Sponsor
K
Krankenhaus Barmherzige Schwestern Linz
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the quality of life outcomes for patients with acute complicated and chronic recurrent diverticulitis affecting the left side of the colon. This study includes patients diagnosed with specific types of diverticulitis confirmed by CT scan or ultrasound. The goal is to compare early versus elective surgical removal of the affected colon segment and evaluate how these approaches impact patient recovery and well-being. Participants are randomly assigned to one of two groups. Group A will receive an early left hemicolectomy 7 to 10 days after hospital admission following initial antibiotic treatment and possible abscess drainage. Group B will have an elective surgery scheduled 6 to 8 weeks after discharge, also following initial conservative treatment. Both groups undergo similar diagnostic procedures before surgery. Throughout the study, patients complete standardized questionnaires assessing gastrointestinal quality of life and general health at multiple times: before surgery, 6 to 8 weeks after surgery, and again 6 to 8 weeks later. Researchers monitor complications like anastomosis issues, mortality, and hospital stay length. The study lasts up to 18 weeks per participant, with ongoing assessments to understand the effects of surgery timing on recovery and quality of life.
CONDITIONS
Brief Title
Quality of Life in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent to participate in the study
- Diagnosis of acute complicated left-sided diverticulitis type CDD 2a or 2b
- Diagnosis of relapsing diverticulitis type CDD 3b with more than 2 episodes within 2 years
- Acute symptoms present at hospital admission
- Inflammation confirmed by CT scan or ultrasound performed by experienced radiologists
- Inflammation located in the left side of the colon
You will not qualify if you...
- Younger than 18 years old
- Pregnancy
- Body mass index greater than 55 kg/m2
- Current colorectal cancer in the left-sided colon
- Taking oral or intravenous corticosteroids
- Undergoing chemotherapy currently
- History of previous left hemicolectomy
- Unable to care for oneself at home or follow instructions
- Not fit for surgery based on anesthesia or specialist evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 to 10 days
Participants receive initial conservative or interventional treatment such as antibiotics, analgesics, and drainage as needed.
1 to 2 visits depending on treatment needs
Duration - Up to 2 days (early surgery) or 6 to 8 weeks (elective surgery)
Participants undergo left hemicolectomy surgery either early (within 2 days after initial treatment) or elective (6 to 8 weeks after initial treatment) depending on randomization.
1 surgery visit
Duration - Up to 18 weeks
Participants complete questionnaires and are monitored for recovery, complications, and quality of life after surgery.
Multiple follow-up visits over 18 weeks
Trial Site Locations
Total: 4 locations
1
Ordensklinikum Elisabethinen Linz
Linz, Austria, Austria, 4020
Actively Recruiting
2
Krankenhaus Barmherzige Schwestern Linz
Linz, Upper Austria, Austria, 4010
Actively Recruiting
3
Kepler University Hospital
Linz, Upper Austria, Austria, 4020
Actively Recruiting
4
Universitätsklinikum Mannheim
Mannheim, Mannheim, Germany, 68167
Not Yet Recruiting
Research Team
S
Sandra Raab, Dr.
A
Andreas Shamiyeh, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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