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

University Hospital Basel

Status

Completed

Conditions

Diverticulitis of Sigmoid

Treatments

Procedure: elective sigmoidectomy

Study type

Observational

Funder types

Other

Identifiers

NCT03994978

FRESCO Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment

252 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)