DATE Trial: Outcomes and Quality of Life in Patients With Early Versus Elective Resection in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Kepler University Hospital
RECRUITING
Linz
Krankenhaus Barmherzige Schwestern Linz
RECRUITING
Linz
Ordensklinikum Elisabethinen Linz
RECRUITING
Linz
Germany
Universitätsklinikum Mannheim
NOT_YET_RECRUITING
Mannheim
Contact Information
Primary
Sandra Raab, Dr.
sandra.raab@kepleruniklinikum.at
+43 (0)5 7680 83 - 78470
Backup
Andreas Shamiyeh, Dr.
andreas.shamiyeh@kepleruniklinikum.at
+43 (0)5 7680 83 - 2133
Time Frame
Start Date: 2023-01-16
Estimated Completion Date: 2027-07
Participants
Target number of participants: 136
Treatments
Experimental: 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
Other: 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
Sponsors
Leads: Kepler University Hospital
Collaborators: Universitätsmedizin Mannheim, Krankenhaus Barmherzige Schwestern Linz, Elisabethinen Hospital

This content was sourced from clinicaltrials.gov