DATE
DATE Trial: Outcomes and Quality of Life in Patients With Early Versus Elective Resection in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis
Sponsor study identifier
interventional
136
2 countries
4
Study Start
January 16, 2023
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 16, 2023
Actual (reported)June 7, 2023
Actual (reported)July 12, 2023
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Gastrointestinal Quality of Life Index
Quality of Life
Up to 18 weeks
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
Intraoperative complication
Up to 18 weeks
Exitus
Up to 18 weeks
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
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
Timing of sigmoid resection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Ordensklinikum Elisabethinen Linz
Linz, Austria, 4020, Austria
Krankenhaus Barmherzige Schwestern Linz
Linz, Upper Austria, 4010, Austria
Andreas Shamiyeh, Dr.
Kepler University Hospital Linz
First Submitted
June 7, 2023
First Posted
July 12, 2023
Study Start
January 16, 2023
Actual (reported)Primary Completion
December 2026
EstimatedClinical Trial With MBK-01, Intestinal Microbiota Capsules, for the Treatment of Patients With Recurrent Diverticulitis
Contact the study team to confirm eligibility.
Kepler University Hospital
Linz, Upper Austria, 4020, Austria
Universitätsklinikum Mannheim
Mannheim, Mannheim, 68167, Germany
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 18, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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