Clinical trial NCT05393609: Quality of Life and Surgery in Diverticular Disease
Official title: Quality of Life and Surgery in Diverticular Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diverticulitis Colon
Quality of Life
Diverticular Disease of Left Side of Colon
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Randers Regional Hospital
First posted: 2022-05-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health related quality of life
timeFrame: Change from baseline to 1 year follow-up.
measure: Disease-specific quality of life
timeFrame: Baseline.
Secondary outcomes:
measure: Generic quality of life
timeFrame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
measure: Bowel function
timeFrame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
measure: Bowel function
timeFrame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
measure: Pain related to diverticular disease
timeFrame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
measure: Urinary dysfunction - females
timeFrame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
measure: Urinary dysfunction - males
timeFrame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
measure: Sexual dysfunction - females
timeFrame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
measure: Sexual dysfunction - males
timeFrame: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.
measure: Postoperative morbidity
timeFrame: 30 days
measure: Postoperative mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Randers Regional Hospital
state: Central Denmark Region
Study officials:
affiliation: Randers Regional Hospital
name: Helene R Dalby, MD
role: PRINCIPAL_INVESTIGATOR
References: