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Natural History of Sigmoid Diverticulitis: The Geneva Cohort Study

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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
Sponsor:
Information provided by:
University Hospital, Geneva

Tracking Information
First Submitted Date November 17, 2009
First Posted Date November 18, 2009
Last Update Posted Date June 25, 2010
Study Start Date January 2007
Estimated Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Natural History of Sigmoid Diverticulitis: The Geneva Cohort Study
Official Title Not Provided
Brief Summary

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
Detailed Description

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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

This cohort study is designed in order to detect recurrent episodes of diverticulitis in a population of patients who were previously admitted in our institution for a first episode.

4.1. Study population

The cohort will consist in the population of patients with CT-scan demonstrated, endoscopy-proven sigmoid diverticulitis who will be admitted in the Department of Surgery of the University Hospital Geneva from January 1st, 2010 to December 31st, 2019. At baseline, participants are between the ages of 18 and 90, and medical information will be updated every year until the end of follow-up, which is December 31st, 2020.

Condition Diverticulitis
Intervention Procedure: laparoscopid sigmoid resection
A second episode of diverticulitis will be treated with IV antibiotics and documented with CT scan and blood tests
Study Groups/Cohorts Diverticulitis of the sigmoid colon - first episode
Intervention: Procedure: laparoscopid sigmoid resection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November¬†17,¬†2009)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2017
Estimated Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

4.2. 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
  • A first episode of complicated diverticulitis (Hinchey I or II - see definition), requiring CT scan-guided percutaneous drainage, and successfully managed without surgery in a patient either unfit for, or refusing to undergo elective sigmoid resection Exclusion criteria
  • Age < 18 or > 90
  • Associated condition of the colon or rectum (cancer, IBD, polyps)
  • Patient unable to communicate in French, English or German
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01015378
Other Study ID Numbers CODIGE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pascal Gervaz, Department of Surgery, University Hospital and Medical School Geneva SWitzerland
Study Sponsor University Hospital, Geneva
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Geneva
Verification Date November 2009