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NCT00692393 Clinical Trial

Primary vs. Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis a Prospective Randomized Trial

Peritonitis Clinical Trial

— DIVERTI  

Official title:
Primary vs. Secondary Anastomosis After Sigmoid Colon Resection for Perforated Diverticulitis (Hinchey Stage III and IV): a Prospective Multicentric Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00692393
Other study ID # 2006/103/HP
Secondary ID
Status Completed
Phase N/A
First received June 3, 2008
Last updated June 18, 2014
Start date June 2008
Est. completion date November 2013

Study information
Verified date June 2014
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Direction Générale de la Santé
Study type Interventional

Clinical Trial Summary

This study compares primary resection with anastomosis and Hartmann's procedure in an adult population with acute perforated colonic diverticulitis (Hinchey Stage III and IV) METHODS: The primary end point was postoperative mortality. Secondary end points included surgical and medical morbidity, operative time, and length of postoperative hospitalization.

Description:

inclusion criteria: hinchey III and IV diverticulitis

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date November 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient with peritonitis du to sigmoid diverticulum complication

- Surgeon - anesthetist confirming the 2 surgeries can be performed

Exclusion Criteria:

- Physical state which can not permit patient to participate

- contraindication to surgery

- non-diverticulum peritonitis

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Hartmann intervention
sigmoid resection, peritoneal and rectal lavage, terminal stoma
• Protected anastomosis resection
sigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma

Locations
Country Name City State
France CHU - Rouen Rouen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Death rate comparison between two chirurgical strategies 18 months Yes
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