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Clinical Trial 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.


Clinical Trial 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. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05393609
Study type Observational [Patient Registry]
Source University of Aarhus
Contact Helene R Dalby, MD
Phone +45 42 65 93 92
Email helecl@rm.dk
Status Recruiting
Phase
Start date April 22, 2022
Completion date March 2025

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