DATE Trial: Outcomes and Quality of Life in Patients With Early Versus Elective Resection in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 136
- Locations
- 8
- Primary Endpoint
- Gastrointestinal Quality of Life Index
Study Overview
Brief Summary
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.
Detailed Description
Primary endpoints:
Gastrointestinal Quality of Life Index (GIQLI)
Secondary endpoints:
SF-36 score (physical and mental health summary scores), LARS score, GIQLI-domains, anastomosis insufficiency and other complications, exitus and length of hospital stay
Treatment strategy:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •< 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
Arms & Interventions
Group A (Early)
Early left hemicolectomy immediately up to a maximum of 2 days after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage) and CT scan/ultrasound proven left-sided colonic diverticulitis
Intervention: Sigmoid resection (Procedure)
Group B (Late)
Elective left hemicolectomy 6 to 8 weeks after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage) and CT scan/ultrasound proven left-sided colonic diverticulitis
Intervention: Sigmoid resection (Procedure)
Outcomes
Primary Outcomes
Gastrointestinal Quality of Life Index
Time Frame: Up to 18 weeks
Quality of Life
Secondary Outcomes
- SF-36 score (Short form score)(Up to 18 weeks)
- Low anterior resection syndrome score(Up to 18 weeks)
- Anastomosis insufficiency(Up to 18 weeks)
- Exitus(Up to 18 weeks)
- Length of stay (sum of days in hospital until end of study)(Up to 18 weeks)
- Earlier readmission due to recurrence while waiting for surgery(Up to 18 weeks)
- Postoperative complication(Up to 18 weeks)
- Intraoperative complication(Up to 18 weeks)