Natural History of Sigmoid Diverticulitis: The Geneva Cohort Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Aim: This is a longitudinal cohort study to assess long-term clinical outcome of patients who were admitted in our institution for a first episode of uncomplicated sigmoid diverticulitis.

Methods: All patients who were diagnosed with a first episode of sigmoid diverticulitis will be evaluated for inclusion in the study, pending informed consent. Those patients who have evidence of complicated diverticulitis (fistula, abscess) will receive a recommendation to undergo elective sigmoid resection, while those who have a simple attack will be recruited in the cohort. Follow-up will be performed at yearly intervals through telephone interview with the patient. The duration of study is expected to last 10 years (2010-2020), with \>50 new patients/year, for a total of \>500 patients.

Endpoints:

1. the occurrence of a second episode of diverticulitis
2. severity and outcome of recurrent diverticulitis
3. evolution in digestive symptoms and quality of life (QoL)
4. need for subsequent elective or emergency sigmoid resection

Rationale: This study will help in determining the risk/benefit of the current approach for this common condition, which is to manage patients conservatively with antibiotics and adopt a wait-and-see attitude. Specifically, the following events will be assessed quantitatively:

* the rate of relapse in an urban community.
* the burden of this common disease on QoL and digestive function
* the percentage of patients who may need emergency surgery

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Italian Study Group on Complicated Diverticulosis

NCT01276886

Diverticulitis

COMPLETED

The Out-patient, Non Antibiotic Management of Patients With Acute Uncomplicated Colonic Diverticulitis

NCT01515150

Colonic Diverticulitis

COMPLETED

A National Study of Clinical Results After Emergency Operation for Perforated Diverticulitis

NCT03332550

Perforated Diverticulitis

COMPLETED

Evaluation of Laparoscopic Peritoneal Lavage for Perforated Diverticulitis: A National Registry - Based Study

NCT05893095

Diverticular Disease of Colon Diverticulitis, Colonic Peritonitis +2 more

COMPLETED

Towards a Tailored Approach for Patients With Acute Diverticulitis and Abscess Formation. A Multicenter Cohort Analysis

NCT06109506

Acute Diverticulitis Diverticular Diseases Diverticulitis of Sigmoid +3 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Colonic diverticulosis is an increasingly common condition in the Western societies; in our country, a third of the population is affected by the 6th decade and two-thirds by the 9th decade. Fortunately, a majority of patients with diverticulosis remain asymptomatic; diverticulitis, the most common presentation of diverticular disease, has an estimated incidence of 10 patients per 100,000/year.

The diagnosis of sigmoid diverticulitis is usually suspected clinically in a patient presenting with acute lower abdominal pain, associated with an inflammatory syndrome with elevated CRP and/or leukocytes count. The preferred imaging modality to establish definitive diagnosis is computerized tomography (CT) scan with triple (oral, intravenous and intra-rectal) administration of contrast. CT scan may also influence management by demonstrating whether sigmoid diverticulitis is simple (phlegmonous, showing an infiltration of pericolic fat and a thickening of intestinal wall) or complicated (abscess, fistula or peritonitis).

A majority of patients present with simple diverticulitis, and will be conservatively and successfully managed with antibiotics alone. Full colonoscopy is performed eventually, in order to rule out an associated condition, most notably cancer and Crohn's disease. Colonic diverticular disease is usually restricted to the sigmoid colon, and conservative treatment with antibiotics is indicated in cases of a first attack of uncomplicated diverticulitis, the rationale being that a majority of patients treated for a first episode of acute inflammation will eventually recover and have no further problems.

Elective sigmoidectomy is currently recommended in the following clinical situations:

* Patients who had two episodes of uncomplicated diverticulitis.
* Patients who had one episode of complicated (perforated) diverticulitis, with either pericolic of pelvic abscesses (Hinchey stage I and II respectively), fistula formation and/or stenosis.

These guidelines, however, reflect expert consensus rather than scientific evidence; currently, there is no way to predict for each patient the risk for developing subsequent complications and recurrences. Thus, the important question is to determine whether a conservative approach is not simply delaying definitive treatment and expose patients to additional complications and alterations in quality of life.

3\. OBJECTIVES

The main objective of this study is to assess the natural history of sigmoid diverticulitis in a cohort of patients living in an urban community, who had radiological and endoscopic evidence of diverticular disease, who benefited initially from adequate antibiotherapy, received dietary counselling, and were followed for a long period of time. In order to do that, we will assess prospectively the following variables:

3.1. Primary endpoints

* Annual rate of recurrent diverticulitis
* Severity and timing of recurrent episodes
* Quality of Life and gastrointestinal symptoms assessed with the GIQLI questionnaire

3.2. Secondary endpoints

* Risk for undergoing emergency surgery
* Surgical morbidity/mortality

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diverticulitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diverticulitis of the sigmoid colon - first episode

laparoscopid sigmoid resection

Intervention Type PROCEDURE

A second episode of diverticulitis will be treated with IV antibiotics and documented with CT scan and blood tests

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

laparoscopid sigmoid resection

A second episode of diverticulitis will be treated with IV antibiotics and documented with CT scan and blood tests

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Informed consent
* A first episode of uncomplicated diverticulitis (see definitions), which was documented with CT scan, required hospital admission, and was successfully managed with intravenous antibiotics Or