Quality of Life and Surgery in Diverticular Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Diverticulitis Colon; Diverticular Disease of Left Side of Colon
• Intervention / Treatment: Procedure: Sigmoidectomy; Dietary supplement: Conservative

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Helene R Dalby, MD; Phone Number: +45 42 65 93 92; Email: helecl@rm.dk
• Study Contact Backup: Name: Katrine J Emmertsen, MD, PhD; Email: katremme@rm.dk

Study Locations

• Denmark
  • Central Denmark Region
    • Randers, Central Denmark Region, Denmark, 8930
      • Recruiting
      • Randers Regional Hospital
      • Contact: Helene R Dalby, MD; Phone Number: +4526353245; Email: helecl@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients with recurrent or chronic diverticular disease referred to a surgical department in Central or Northern Denmark Region.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sigmoidectomy; Patients with diverticular disease undergoing elective resection of the sigmoid colon	Procedure: Sigmoidectomy; Conventional laparoscopic resection of the sigmoid colon
Conservative; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Disease-specific quality of life	Diverticulitis quality of life (DV-QoL) 16 items. Total score 0-10 (0= best,10=worst).	Baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
Postoperative morbidity	Postoperative complications classified according to the Clavien-Dindo classification	30 days
Postoperative mortality	Mortality within the postoperative period	30 days

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Randers Regional Hospital
• Investigators: Principal Investigator: Helene R Dalby, MD, Randers Regional Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Diverticulosis, Colonic; Diverticulitis; Diverticulum; Diverticular Diseases; Diverticulitis, Colonic
• Other Study ID Numbers: Life with diverticular disease

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No