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

Sponsor

Kepler University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05942833

Collaborator

Krankenhaus Barmherzige Schwestern Linz (Other), Elisabethinen Hospital (Other)

136

Enrollment

Locations

Arms

34.5

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diverticulitis of Sigmoid	Procedure: Sigmoid resection	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, randomized controlledprospective, randomized controlled

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 16, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Gastrointestinal Quality of Life Index [Up to 18 weeks]
Quality of Life

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Krankenhaus Barmherzige Schwestern Linz	Linz	Upper Austria	Austria	4010
2	Kepler University Hospital	Linz	Upper Austria	Austria	4020
3	Ordensklinikum Elisabethinen Linz	Linz		Austria	4020
4	Universitätsklinikum Mannheim	Mannheim		Germany	68167