Quality of Life and Surgery in Diverticular Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Aarhus
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- Health related quality of life
Study Overview
Brief Summary
Diverticular disease is one of the most common diseases of the gastrointestinal tract in industrial countries. Prevalence and admission rate due to diverticular disease increases.
Symptomatic patients usually present with acute uncomplicated or complicated diverticulitis. Recurrence rates of complicated diverticulitis are estimated to 10-30%. Recurrences, chronic complications or persisting pain, here collectively referred to as chronic diverticular disease, may be treated by elective sigmoidectomy. Currently, there is no specific criteria for elective surgery, but only a recommendation of a tailored approach depending on the patient's symptoms.
It is well established that diverticular disease has a negative impact on quality of life (QoL). Elective laparoscopic sigmoidectomy may increase QoL.
In this prospective study, we will prospectively examine QoL, patient-related outcomes and peri- and postoperative outcome of elective sigmoidectomy for chronic diverticular disease, and compare it to conservatively treated patients.
Detailed Description
Design: Prospective, multicentre, observational
Locations: Hospitals in Central and Northern Denmark Region (6 hospitals).
Time: Recruitment starts in April 2022 and is planned to be completed in 2024.
Patients: All patients referred to a surgical clinic due to chronic diverticular disease.
Allocation for surgery or conservative treatment: Patients will be treated according to Danish National Guidelines for treatment of diverticular disease. The study will not influence the treatment of the patient, but only observe and evaluate current daily practice.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Health related quality of life
Time Frame: Change from baseline to 1 year follow-up.
Gastrointestinal Quality of Life (GIQLI) 36 items. Total score 0-144 (0=worst, 144=best).
Disease-specific quality of life
Time Frame: Baseline.
Diverticulitis quality of life (DV-QoL) 16 items. Total score 0-10 (0= best,10=worst).
Secondary Outcomes
- Pain related to diverticular disease(Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.)
- Generic quality of life(Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.)
- Urinary dysfunction - males(Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.)
- Sexual dysfunction - females(Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.)
- Urinary dysfunction - females(Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.)
- Sexual dysfunction - males(Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.)
- Postoperative morbidity(30 days)
- Postoperative mortality(30 days)
- Bowel function(Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.)