Clinical trial NCT03994978: Bowel Function/QoL After Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis
Official title: Preoperative vs. Postoperative Bowel Function and Quality of Life in Patients Undergoing Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis (FRESCO-Trial)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diverticulitis of Sigmoid
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 252
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: Patients with recurrent episodes of diverticulitis with indication of further treatment.The physician decides which therapy (conservative or surgical) will be carried out.

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in grade of fecal incontinence incontinence score
timeFrame: change from baseline to 12 months after intervention
measure: Change in grade of constipation
timeFrame: change from baseline to 12 months after intervention
Secondary outcomes:
measure: Change in gastrointestinal quality of Life: gastrointestinal quality of life score" (GIQLI score)
timeFrame: change from baseline to 12 months after intervention
measure: Change in erectile function
timeFrame: change from baseline to 12 months after intervention
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St. Claraspital Basel
Study officials:
affiliation: St. Clara Research Ltd.
name: Bettina Wölnerhanssen, MD
role: STUDY_CHAIR
affiliation: Clarunis
name: Daniel Steinemann, MD
role: PRINCIPAL_INVESTIGATOR
References: