Quality of Life and Surgery in Diverticular Disease
- Conditions
- Diverticulitis ColonDiverticular Disease of Left Side of ColonQuality of Life
- Interventions
- Dietary Supplement: ConservativeProcedure: Sigmoidectomy
- Registration Number
- NCT05393609
- Lead Sponsor
- University of Aarhus
- 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.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- Referred to surgical clinic due to diverticular disease
- Colonic diverticula verified by CT or endoscopy
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Conservative Conservative Patients with diverticular disease not referred to surgery, but conservative treatment Sigmoidectomy Sigmoidectomy Patients with diverticular disease undergoing elective resection of the sigmoid colon
- Primary Outcome Measures
Name Time Method Health related quality of life 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 Baseline. Diverticulitis quality of life (DV-QoL) 16 items. Total score 0-10 (0= best,10=worst).
- Secondary Outcome Measures
Name Time Method Pain related to diverticular disease Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up. Modified Rectal Cancer Pain Score 7 items. Total score 0-45 (0= best, 45= worst). 7 item. Total score 0-29 (0= worst, 65= best).
Generic quality of life Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up. EuroQol-5 Domain 5-level (EQ-5D-5L) 5 items. Total score 5-25 (5=best. 25 = worst). Visual analog scale 0-100 (0=worst, 100= best).
Urinary dysfunction - males Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up. International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) 14 items. Total score 0-56 (0=best, 56=worst).
Sexual dysfunction - females Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up. Modified Rectal Cancer Female Sexuality Score 7 items. Total score 0-29 (0=best, 29= worst). 14 item. Total score 0-56 (0=best, 56=worst).
Bowel function Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up. Low anterior resection syndrome score (LARS score) 5 items. Total score 0-42 (0=best, 42=worst).
Urinary dysfunction - females Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up. International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (CIQ-FLUTS) 13 items. Total score 0-52 (0=best, 52=worst).
Sexual dysfunction - males Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up. The International Index of Erectile Function Questionnaire (IIEF) 15 items. Total score 0-65 (0= worst, 65= best).
Postoperative morbidity 30 days Postoperative complications classified according to the Clavien-Dindo classification
Postoperative mortality 30 days Mortality within the postoperative period
Trial Locations
- Locations (1)
Randers Regional Hospital
🇩🇰Randers, Central Denmark Region, Denmark