Quality of Life and Surgery in Diverticular Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Health related quality of life [Change from baseline to 1 year follow-up.]
Gastrointestinal Quality of Life (GIQLI) 36 items. Total score 0-144 (0=worst, 144=best).
- Disease-specific quality of life [Baseline.]
Diverticulitis quality of life (DV-QoL) 16 items. Total score 0-10 (0= best,10=worst).
Secondary Outcome Measures
- Generic quality of life [Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
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).
- Bowel function [Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
Patient-assessment of constipation symptoms (PAC-SYM) 12 items. Total score 0-50 (0=best, 50=worst).
- Bowel function [Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
Low anterior resection syndrome score (LARS score) 5 items. Total score 0-42 (0=best, 42=worst).
- Pain related to diverticular disease [Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
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).
- Urinary dysfunction - females [Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (CIQ-FLUTS) 13 items. Total score 0-52 (0=best, 52=worst).
- Urinary dysfunction - males [Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) 14 items. Total score 0-56 (0=best, 56=worst).
- Sexual dysfunction - females [Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
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).
- Sexual dysfunction - males [Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
The International Index of Erectile Function Questionnaire (IIEF) 15 items. Total score 0-65 (0= worst, 65= best).
- Postoperative morbidity [30 days]
Postoperative complications classified according to the Clavien-Dindo classification
- Postoperative mortality [30 days]
Mortality within the postoperative period
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Randers Regional Hospital | Randers | Central Denmark Region | Denmark | 8930 |
Sponsors and Collaborators
- University of Aarhus
- Randers Regional Hospital
Investigators
- Principal Investigator: Helene R Dalby, MD, Randers Regional Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Life with diverticular disease