Quality of Life and Surgery in Diverticular Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Quality of Life and Surgery in Diverticular Disease

Conditions
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Diverticulitis Colon, Quality of Life, Diverticular Disease of Left Side of Colon

Intervention / Treatment
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* Procedure: Sigmoidectomy
* Dietary Supplement: Conservative


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sigmoidectomy<br>Patients with diverticular disease undergoing elective resection of the sigmoid colon | Procedure: Sigmoidectomy<br>* Conventional laparoscopic resection of the sigmoid colon<br>|
| Conservative<br>Patients with diverticular disease not referred to surgery, but conservative treatment | Dietary Supplement: Conservative<br>* According to current practice including advice on supplementary dietary fiber, analgetics, or laxatives when indicated.<br>|

What is the study measuring?
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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 |