Bowel Function/QoL After Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis

Study Overview
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Brief Summary
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The decision to perform a surgical intervention or not after recovery from repeated uncomplicated episodes of acute diverticulitis remains controversial and the literature shows different conflicting approaches based on low-quality evidence.The goal of this trial is to achieve a better understanding of the impact of surgery on bowel function and QoL in patients with recurrent uncomplicated sigmoid diverticulitis in order to develop treatment guidelines.

Detailed Description
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The prevalence of diverticular disease of sigmoid in the Western has increased over the past century and our know-how of this disease and its management continues to evolve. International experts have tried to standardize the surgical approach to patients with recurrent episodes of sigmoid diverticulitis but, to date, no guidelines are universally recognized.The American Society of Colon and Rectal Surgeons (ASCRS) and the World Society of Emergency Surgery (WSES) recommend an individualized approach after recovery from uncomplicated acute diverticulitis to plan an elective sigmoid resection. The impact of ongoing disorders on quality of life (QoL) and not the number of previous episodes of diverticulitis should be the most determining factor. The German guideline by the Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie (DGAV) recommend an elective sigmoid resection after a careful risk/benefit assessment depending on the clinical presentation in the disease-free interval in patients with chronic relapsing diverticulitis.The Danish Surgical Society (DSS) is more restrained and mentions the unnecessary risk in terms of morbidity and mortality to the individual as well as costs to society in prophylactic resection of the sigmoid. Therefore, they recommend that elective surgery should be probably limited to symptomatic cases not amenable to conservative measures. Moreover, recent studies have demonstrated that the number of attacks of diverticulitis is not necessarily a prevailing factor in defining the suitability of surgery and the operation itself carries significant morbidity and mortality. The German guidelines describe also a persistence of the symptoms in patients who underwent sigmoid resection in 22-25%. An uncomplicated diverticulitis is generally considered a mild and self-limiting disease, performing a potentially harmful procedure in these patients does not seem justified. However, elective resection may be an appropriate solution for a more selective group of patients who suffer greatly from their disease. Many studies have consistently shown that 40-80% remain symptomatic after conservative treatment, leading to impaired health-related Quality of life (HRQoL) and increased costs.

Official Title
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Preoperative vs. Postoperative Bowel Function and Quality of Life in Patients Undergoing Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis (FRESCO-Trial)

Conditions
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Diverticulitis of Sigmoid

Intervention / Treatment
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* Procedure: elective sigmoidectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with recurrent uncomplicated diverticulitis and surgical indication for sigmoid resection Patients with recurrent uncomplicated diverticulitis and non-surgical indication for conservative management Confirmation of at least one episode of acute uncomplicated diverticulitis in computed tomography Exclusion Criteria: Patients aged under 18. Patients unable to understand an informed consent. Patients with chronic pain disorder. Patients with sigmoid fistulas Emergency operations. Pregnant women or lactation. Patients with other severe gastrointestinal diseases, such as inflammatory bowel diseases (IBD), carcinoma or immunologic disorders. Patients unable to perform surgery or high-risk patients according to the American Society of Anesthesiology (ASA 4 grade or higher)

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 |
| --- | --- |
| Surgical group<br>Patients with uncomplicated recurrent diverticulitis undergoing elective sigmoid resection | Procedure: elective sigmoidectomy<br>* elective sigmoidectomy<br>|
| Conservative group<br>Patients with uncomplicated recurrent diverticulitis with conservative treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in grade of fecal incontinence incontinence score | Fecal incontinence measured by total Vaizey-Wexner incontinence score ranging from 0 to 24; lower values represent better outcome | change from baseline to 12 months after intervention | 
| Change in grade of constipation | Constipation measured by total Cleveland constipation score ranging from 0 to 30; lower values represent better outcome | change from baseline to 12 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gastrointestinal quality of Life: gastrointestinal quality of life score (GIQLI score) | Gastrointestinal quality of life measured by total gastrointestinal quality of life score (GIQLI score) ranging from 0-144; higher values represent better outcome | change from baseline to 12 months after intervention | 
| Change in erectile function | Erectile function measured by total international index of erectile function (IIEF-5-score) ranging from 5 to 25; higher values represent better outcome | change from baseline to 12 months after intervention |