NCT05942833 Quality of Life in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis
| NCT ID | NCT05942833 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kepler University Hospital |
| Condition | Diverticulitis of Sigmoid |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2023-01-16 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 136 participants in total. It began in 2023-01-16 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Andreas Shamiyeh, Dr.
PRINCIPAL INVESTIGATOR
Kepler University Hospital Linz
Frequently Asked Questions
Who can join the NCT05942833 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diverticulitis of Sigmoid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05942833 currently recruiting?
Yes, NCT05942833 is actively recruiting participants. Contact the research team at sandra.raab@kepleruniklinikum.at for enrollment information.
Where is the NCT05942833 trial being conducted?
This trial is being conducted at Linz, Austria, Linz, Austria, Linz, Austria, Mannheim, Germany.
Who is sponsoring the NCT05942833 clinical trial?
NCT05942833 is sponsored by Kepler University Hospital. The principal investigator is Andreas Shamiyeh, Dr. at Kepler University Hospital Linz. The trial plans to enroll 136 participants.