NCT01015378

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:

  • 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

June 25, 2010

Status Verified

November 1, 2009

Enrollment Period

5 years

First QC Date

November 17, 2009

Last Update Submit

June 24, 2010

Conditions

Diverticulitis

Keywords

Recurrent sigmoid diverticulitisdiverticulitisColonsigmoidrecurrence

Study Arms (1)

Diverticulitis of the sigmoid colon - first episode

Procedure: laparoscopid sigmoid resection

Interventions

laparoscopid sigmoid resectionPROCEDURE

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

Diverticulitis of the sigmoid colon - first episode

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 or \> 90
  • Associated condition of the colon or rectum (cancer, IBD, polyps)
  • Patient unable to communicate in French, English or German

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Geneva

Geneva, 1211, Switzerland

RECRUITING

Related Publications (2)

  • Scarpa CR, Buchs NC, Poncet A, Konrad-Mugnier B, Gervaz P, Morel P, Ris F. Short-term Intravenous Antibiotic Treatment in Uncomplicated Diverticulitis Does Not Increase the Risk of Recurrence Compared to Long-term Treatment. Ann Coloproctol. 2015 Apr;31(2):52-6. doi: 10.3393/ac.2015.31.2.52. Epub 2015 Apr 30.

    PMID: 25960972DERIVED

  • Buchs NC, Konrad-Mugnier B, Jannot AS, Poletti PA, Ambrosetti P, Gervaz P. Assessment of recurrence and complications following uncomplicated diverticulitis. Br J Surg. 2013 Jun;100(7):976-9; discussion 979. doi: 10.1002/bjs.9119. Epub 2013 Apr 17.

    PMID: 23592303DERIVED

MeSH Terms

Conditions

DiverticulitisRecurrence

Condition Hierarchy (Ancestors)

Diverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

January 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2017

Last Updated

June 25, 2010

Record last verified: 2009-11

Locations

CH(1)