Examining quality of life in patients with diverticular disease undergoing surgery
Quality of Life and Surgery in Diverticular Disease
This study looks at how surgery for diverticular disease affects the quality of life for patients compared to those who choose not to have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Randers, Central Jutland) |
| Trial ID | NCT05393609 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with chronic diverticular disease who are referred to surgical clinics in Denmark. It aims to assess the quality of life and patient-related outcomes following elective laparoscopic sigmoidectomy compared to conservative treatment. Patients will complete questionnaires at the start of the study and again after one year, with additional follow-ups for those who undergo surgery. The study will not alter treatment decisions but will evaluate current practices in managing diverticular disease.
Who should consider this trial
Good fit: Ideal candidates are patients referred to surgical clinics for chronic diverticular disease with confirmed colonic diverticula.
Not a fit: Patients with previous colorectal surgeries, cancer, inflammatory bowel disease, or psychiatric disorders affecting questionnaire responses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how elective surgery impacts the quality of life for patients with chronic diverticular disease.
How similar studies have performed: While there is existing literature on the impact of surgical interventions on quality of life in diverticular disease, this study's specific observational approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Referred to surgical clinic due to diverticular disease * Colonic diverticula verified by CT or endoscopy Exclusion Criteria: * Previous colonic resection other than appendectomy * Previous or current colorectal cancer * Previous or current disseminated cancer * Inflammatory bowel disease * Psychiatric disorder influencing the ability to answer questionnaires * Inadequate Danish
Where this trial is running
Randers, Central Jutland
- Randers Regional Hospital — Randers, Central Jutland, Denmark (Recruiting)
Study contacts
- Principal investigator: Helene R Dalby, MD — Randers Regional Hospital
- Study coordinator: Helene R Dalby, MD
- Email: helecl@rm.dk
- Phone: +45 42 65 93 92
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.