Quality of Life and Surgery in Diverticular Disease

University of Aarhus

Status: Enrolling

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

Treatments: Dietary Supplement: Conservative; Procedure: Sigmoidectomy

Study type: Observational

Funder types: Other

Identifiers

NCT05393609

Life with diverticular disease

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

Sigmoidectomy

Description:

Patients with diverticular disease undergoing elective resection of the sigmoid colon

Treatment:

Procedure: Sigmoidectomy

Conservative

Description:

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

Treatment:

Dietary Supplement: Conservative