Natural History of Sigmoid Diverticulitis: The Geneva Cohort Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01015378|
Recruitment Status : Unknown
Verified November 2009 by University Hospital, Geneva.
Recruitment status was: Recruiting
First Posted : November 18, 2009
Last Update Posted : June 25, 2010
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.
- the occurrence of a second episode of diverticulitis
- severity and outcome of recurrent diverticulitis
- evolution in digestive symptoms and quality of life (QoL)
- 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
|Condition or disease||Intervention/treatment|
|Diverticulitis||Procedure: laparoscopid sigmoid resection|
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.
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
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||January 2017|
|Diverticulitis of the sigmoid colon - first episode||
Procedure: laparoscopid sigmoid resection
A second episode of diverticulitis will be treated with IV antibiotics and documented with CT scan and blood tests
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015378
|University Hospital Geneva||Recruiting|
|Geneva, Switzerland, 1211|
|Contact: Beatrice Konrad email@example.com|
|Principal Investigator: Pascal Gervaz, MD|