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Natural History of Sigmoid Diverticulitis: The Geneva Cohort Study

NCT01015378 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2010-06-25

No results posted yet for this study

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

Conditions

  • Diverticulitis

Interventions

PROCEDURE

laparoscopid sigmoid resection

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

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2012-01-31
Completion
2017-01-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01015378 on ClinicalTrials.gov