Quality of Life and Surgery in Diverticular Disease

Quality of Life Clinical Trial

Official title:

Quality of Life and Surgery in Diverticular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05393609
• Other study ID #: Life with diverticular disease
• Status: Recruiting
• Start date: April 22, 2022
• Est. completion date: March 2025

Study information

• Verified date: December 2023
• Source: University of Aarhus
• Contact: Helene R Dalby, MD
• Phone: +45 42 65 93 92
• Email: helecl[@]rm.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Referred to surgical clinic due to diverticular disease
• Colonic diverticula verified by CT or endoscopy

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diverticular Disease of Left Side of Colon
• Diverticulitis
• Diverticulitis Colon
• Diverticulitis, Colonic
• Diverticulum
• Quality of Life

Intervention

Procedure:
• Sigmoidectomy
Conventional laparoscopic resection of the sigmoid colon

Dietary Supplement:
• Conservative
According to current practice including advice on supplementary dietary fiber, analgetics, or laxatives when indicated.

Locations

Country	Name	City	State
Denmark	Randers Regional Hospital	Randers	Central Denmark Region

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Randers Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life	Gastrointestinal Quality of Life (GIQLI) 36 items. Total score 0-144 (0=worst, 144=best).	Change from baseline to 1 year follow-up.
Primary	Disease-specific quality of life	Diverticulitis quality of life (DV-QoL) 16 items. Total score 0-10 (0= best,10=worst).	Baseline.
Secondary	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).	Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Secondary	Bowel function	Patient-assessment of constipation symptoms (PAC-SYM) 12 items. Total score 0-50 (0=best, 50=worst).	Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Secondary	Bowel function	Low anterior resection syndrome score (LARS score) 5 items. Total score 0-42 (0=best, 42=worst).	Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Secondary	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).	Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Secondary	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).	Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Secondary	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).	Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Secondary	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).	Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Secondary	Sexual dysfunction - males	The International Index of Erectile Function Questionnaire (IIEF) 15 items. Total score 0-65 (0= worst, 65= best).	Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
Secondary	Postoperative morbidity	Postoperative complications classified according to the Clavien-Dindo classification	30 days
Secondary	Postoperative mortality	Mortality within the postoperative period	30 days