An observational study in Diverticulitis Colon, Quality of Life and Diverticular Disease of Left Side of Colon, sponsored by University of Aarhus. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by University of Aarhus · Observational
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.
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.
27 studies on the registry are indexed under Diverticulitis, Colonic; 8 are open to participants now.
This study's planned enrollment of 250 is close to the median of 250 across 15 observational studies indexed under Diverticulitis, Colonic.
Browse Diverticulitis, Colonic studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients with recurrent or chronic diverticular disease referred to a surgical department in Central or Northern Denmark Region.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with diverticular disease undergoing elective resection of the sigmoid colon
Procedure: Sigmoidectomy
Patients with diverticular disease not referred to surgery, but conservative treatment
Dietary Supplement: Conservative
Conventional laparoscopic resection of the sigmoid colon
According to current practice including advice on supplementary dietary fiber, analgetics, or laxatives when indicated.
Health related quality of life
Gastrointestinal Quality of Life (GIQLI) 36 items. Total score 0-144 (0=worst, 144=best).
Time frame: Change from baseline to 1 year follow-up.
Disease-specific quality of life
Diverticulitis quality of life (DV-QoL) 16 items. Total score 0-10 (0= best,10=worst).
Time frame: Baseline.
Generic quality of life
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).
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Bowel function
Patient-assessment of constipation symptoms (PAC-SYM) 12 items. Total score 0-50 (0=best, 50=worst).
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Bowel function
Low anterior resection syndrome score (LARS score) 5 items. Total score 0-42 (0=best, 42=worst).
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Pain related to diverticular disease
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).
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Urinary dysfunction - females
International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (CIQ-FLUTS) 13 items. Total score 0-52 (0=best, 52=worst).
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Urinary dysfunction - males
International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) 14 items. Total score 0-56 (0=best, 56=worst).
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Sexual dysfunction - females
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).
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Sexual dysfunction - males
The International Index of Erectile Function Questionnaire (IIEF) 15 items. Total score 0-65 (0= worst, 65= best).
Time frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Postoperative morbidity
Postoperative complications classified according to the Clavien-Dindo classification
Time frame: 30 days
Postoperative mortality
Mortality within the postoperative period
Time frame: 30 days
Plan to share: No
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