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

Diverticulitis of Sigmoid Clinical Trial

— DATE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942833
• Other study ID #: 1203/2022
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: Kepler University Hospital
• Contact: Sandra Raab, Dr.
• Phone: +43 (0)5 7680 83 - 78470
• Email: sandra.raab[@]kepleruniklinikum.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diverticulitis
• Diverticulitis of Sigmoid

Intervention

Procedure:
• Sigmoid resection
Timing of sigmoid resection

Locations

Country	Name	City	State
Austria	Kepler University Hospital	Linz	Upper Austria
Austria	Krankenhaus Barmherzige Schwestern Linz	Linz	Upper Austria
Austria	Ordensklinikum Elisabethinen Linz	Linz
Germany	Universitätsklinikum Mannheim	Mannheim

Sponsors (3)

Lead Sponsor	Collaborator
Kepler University Hospital	Elisabethinen Hospital, Krankenhaus Barmherzige Schwestern Linz

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

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