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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diverticulitis of Sigmoid
• Intervention / Treatment: Procedure: Sigmoid resection

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:

A patient is coming into the hospital with acute symptoms of diverticulitis. The diagnosis must then be confirmed either with ultrasound or with a CT scan. After confirmation the patient is asked to be part of the study. At that point of time the patient does not know his randomization. After the patient's approval and signed consent the patients will bei informed about the further procedure and the appointment of surgery. Questionnaires will now be filled out and antibiotical treatment starts. If necessary a radiological intervention (drainage) is performed.

Is the patient is randomized into Group A he will get 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). If the patient is in Group B he will receive an elective left hemicolectomy 6 to 8 weeks after 7-10 days lasting initial conservative or interventional treatment (e.g: antibiotics, analgesics, drainage).

Reassessment of the questionnaires will bei done in both groups. Group A will be asked 6-8 after surgery and again 6-8 weeks after the second reassessment.

Group B will be asked 6-8 weeks after discharge (directly before surgery) and again 6-8 weeks after surgery.

The aim of the study is to evaluate the outcome and quality of life in patients receiving early surgery versus elective resection of the left-sided colon in acute complicated diverticulitis and chronic recurrent diverticulitis with acute exacerbation.

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra Raab, Dr.; Phone Number: +43 (0)5 7680 83 - 78470; Email: sandra.raab@kepleruniklinikum.at
• Study Contact Backup: Name: Andreas Shamiyeh, Dr.; Phone Number: +43 (0)5 7680 83 - 2133; Email: andreas.shamiyeh@kepleruniklinikum.at

Study Locations

• Austria
  • Austria
    • Linz, Austria, Austria, 4020
      • Recruiting
      • Ordensklinikum Elisabethinen Linz
      • Contact: Matthias Biebl, Dr.; Phone Number: +43 (0)732-7677 - 7300; Email: matthias.biebl@ordensklinikum.at
      • Contact: Christoph Schwaiger-Hengstschläger, Dr.; Phone Number: +43 (0)732-7677 - 7300
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Recruiting
      • Kepler University Hospital
      • Contact: Sandra Raab, Dr.; Phone Number: +43 (0)5 7680 83 - 78470; Email: sandra.raab@kepleruniklinikum.at
      • Contact: Andreas Shamiyeh, Dr.; Phone Number: +43 (0)5 7680 83 - 2133; Email: andreas.shamiyeh@kepleruniklinikum.at
    • Linz, Upper Austria, Austria, 4010
      • Recruiting
      • Krankenhaus Barmherzige Schwestern Linz
      • Contact: Matthias Biebl, Dr.; Phone Number: +43 (0)732-7677 - 7300; Email: matthias.biebl@ordensklinikum.at
      • Contact: Gerd Pressl, Dr.; Phone Number: +43 732 7677 - 7300; Email: gerd.pressl@ordensklinikum.at
• Germany
  • Mannheim
    • Mannheim, Mannheim, Germany, 68167
      • Not yet recruiting
      • Universitätsklinikum Mannheim
      • Contact: Steffen Seyfried, PD MD; Phone Number: +49 621 383-4864; Email: steffen.seyfried@umm.de
      • Contact: Christoph Reißfelder, Prof. MD; Phone Number: +49 621 383-4864; Email: christoph.reißfelder@umm.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: Sigmoid resection; Timing of sigmoid resection
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	Procedure: Sigmoid resection; Timing of sigmoid resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Quality of Life Index	Quality of Life	Up to 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36 score (Short form score)	physical and mental health summary scores (0-100), the higher the better	Up to 18 weeks
Low anterior resection syndrome score	points (0-40), the lower the better	Up to 18 weeks
Anastomosis insufficiency	yes/no	Up to 18 weeks
Intraoperative complication	bleeding, ureter harming (yes/no)	Up to 18 weeks
Exitus	yes/no	Up to 18 weeks
Length of stay (sum of days in hospital until end of study)	days	Up to 18 weeks
Earlier readmission due to recurrence while waiting for surgery	Only in Group B	Up to 18 weeks
Postoperative complication	pneumonia, urinary tract infection (yes/no)	Up to 18 weeks

Collaborators and Investigators

• Sponsor: Kepler University Hospital
• Collaborators: Universitätsmedizin Mannheim; Krankenhaus Barmherzige Schwestern Linz; Elisabethinen Hospital
• Investigators: Principal Investigator: Andreas Shamiyeh, Dr., Kepler University Hospital Linz

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Recurrent diverticulitis; Acute complicated Diverticulitis; Early resection; Elective resection
• Additional Relevant MeSH Terms: Diverticular Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Diverticulitis
• Other Study ID Numbers: 1203/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No