Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2022-04-22
2025-03-31
Brief Summary
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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
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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.
Intervention: Patients will be asked to answer questionnaires at inclusion and again after 1 year. Patients treated with sigmoidectomy will also be asked to answers questionnaires 3 weeks and 3 months after surgery.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Sigmoidectomy
Patients with diverticular disease undergoing elective resection of the sigmoid colon
Sigmoidectomy
Conventional laparoscopic resection of the sigmoid colon
Conservative
Patients with diverticular disease not referred to surgery, but conservative treatment
Conservative
According to current practice including advice on supplementary dietary fiber, analgetics, or laxatives when indicated.
Interventions
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Sigmoidectomy
Conventional laparoscopic resection of the sigmoid colon
Conservative
According to current practice including advice on supplementary dietary fiber, analgetics, or laxatives when indicated.
Eligibility Criteria
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Inclusion Criteria
* Colonic diverticula verified by CT or endoscopy
Exclusion Criteria
* Previous or current colorectal cancer
* Previous or current disseminated cancer
* Inflammatory bowel disease
* Psychiatric disorder influencing the ability to answer questionnaires
* Inadequate Danish
18 Years
ALL
No
Sponsors
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Randers Regional Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Helene R Dalby, MD
Role: PRINCIPAL_INVESTIGATOR
Randers Regional Hospital
Locations
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Randers Regional Hospital
Randers, Central Jutland, Denmark
Countries
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Central Contacts
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Facility Contacts
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Helene R Dalby, MD
Role: primary
Other Identifiers
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Life with diverticular disease
Identifier Type: -
Identifier Source: org_study_id