Quality of Life and Surgery in Diverticular Disease

NCT05393609 | Unknown

• 1 other identifier: Life with diverticular disease
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Diverticulitis Colon; Quality of Life; Diverticular Disease of Left Side of Colon

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Generic quality of life

  Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.

• Bowel function

  Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.

• Bowel function

  Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.

• Pain related to diverticular disease

  Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.

• Urinary dysfunction - females

  Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.

Study Arms (2)

Sigmoidectomy

Patients with diverticular disease undergoing elective resection of the sigmoid colon

Procedure: Sigmoidectomy

Conservative

Patients with diverticular disease not referred to surgery, but conservative treatment

Dietary Supplement: Conservative

Interventions

Sigmoidectomy PROCEDURE

Conventional laparoscopic resection of the sigmoid colon

Sigmoidectomy

Conservative DIETARY_SUPPLEMENT

According to current practice including advice on supplementary dietary fiber, analgetics, or laxatives when indicated.

Conservative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Randers Regional Hospital: collaborator

Study Sites (1)

Randers Regional Hospital

Randers, Central Jutland, 8930, Denmark

RECRUITING

MeSH Terms

Conditions

Diverticulitis, Colonic

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Diverticulitis; Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Diverticulosis, Colonic; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Helene R Dalby, MD

  Randers Regional Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helene R Dalby, MD

CONTACT

+45 42 65 93 92; helecl@rm.dk

Katrine J Emmertsen, MD, PhD

CONTACT

katremme@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 26, 2022
• Study Start: April 22, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)