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

NCT05942833 | Recruiting

• 1 other identifier: 1203/2022
• Study Type: interventional
• Target: 136
• Locations: 2 countries
• Sites: 4

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.

Conditions

Diverticulitis of Sigmoid

Keywords

Recurrent diverticulitis; Quality of life; Acute complicated Diverticulitis; Early resection; Elective resection

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal Quality of Life Index

  Quality of Life

  Up to 18 weeks

Secondary Outcomes (8)

• 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

Study Arms (2)

Group A (Early)

EXPERIMENTAL

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

Group B (Late)

OTHER

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

Interventions

Sigmoid resection PROCEDURE

Timing of sigmoid resection

Group A (Early); Group B (Late)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Elisabethinen Hospital: collaborator
• Universitätsmedizin Mannheim: collaborator
• Kepler University Hospital: lead
• Krankenhaus Barmherzige Schwestern Linz: collaborator

Study Sites (4)

Ordensklinikum Elisabethinen Linz

Linz, Austria, 4020, Austria

RECRUITING

Krankenhaus Barmherzige Schwestern Linz

Linz, Upper Austria, 4010, Austria

RECRUITING

Kepler University Hospital

Linz, Upper Austria, 4020, Austria

RECRUITING

Universitätsklinikum Mannheim

Mannheim, Mannheim, 68167, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Diverticulitis

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Andreas Shamiyeh, Dr.

  Kepler University Hospital Linz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Raab, Dr.

CONTACT

+43 (0)5 7680 83 - 78470; sandra.raab@kepleruniklinikum.at

Andreas Shamiyeh, Dr.

CONTACT

+43 (0)5 7680 83 - 2133; andreas.shamiyeh@kepleruniklinikum.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized controlled

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: July 12, 2023
• Study Start: January 16, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

DE (1); AU (3)