Quality of Life and Surgery in Diverticular Disease
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|ClinicalTrials.gov Identifier: NCT05393609|
Recruitment Status : Recruiting
First Posted : May 26, 2022
Last Update Posted : May 26, 2022
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.
|Condition or disease||Intervention/treatment|
|Diverticulitis Colon Quality of Life Diverticular Disease of Left Side of Colon||Procedure: Sigmoidectomy Dietary Supplement: Conservative|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||250 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Quality of Life and Surgery in Diverticular Disease|
|Actual Study Start Date :||April 22, 2022|
|Estimated Primary Completion Date :||March 2025|
|Estimated Study Completion Date :||March 2025|
Patients with diverticular disease undergoing elective resection of the sigmoid colon
Conventional laparoscopic resection of the sigmoid colon
Patients with diverticular disease not referred to surgery, but conservative treatment
Dietary Supplement: Conservative
According to current practice including advice on supplementary dietary fiber, analgetics, or laxatives when indicated.
- 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).
- Generic quality of life [ Time Frame: 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).
- Bowel function [ Time Frame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up. ]Patient-assessment of constipation symptoms (PAC-SYM) 12 items. Total score 0-50 (0=best, 50=worst).
- Bowel function [ Time Frame: 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).
- Pain related to diverticular disease [ Time Frame: 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).
- Urinary dysfunction - females [ Time Frame: 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).
- Urinary dysfunction - males [ Time Frame: 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 [ Time Frame: 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).
- Sexual dysfunction - males [ Time Frame: 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 [ Time Frame: 30 days ]Postoperative complications classified according to the Clavien-Dindo classification
- Postoperative mortality [ Time Frame: 30 days ]Mortality within the postoperative period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05393609
|Contact: Helene R Dalby, MD||+45 42 65 93 email@example.com|
|Contact: Katrine J Emmertsen, MD, PhDfirstname.lastname@example.org|
|Randers Regional Hospital||Recruiting|
|Randers, Central Denmark Region, Denmark, 8930|
|Contact: Helene R Dalby, MD +4526353245 email@example.com|
|Principal Investigator:||Helene R Dalby, MD||Randers Regional Hospital|