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

Not Applicable

Completed

• Conditions: Peritonitis
• Interventions: Procedure: Hartmann intervention; Procedure: Protected anastomosis resection

• Registration Number: NCT00692393
• Lead Sponsor: University Hospital, Rouen

Brief 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.

Detailed Description

inclusion criteria: hinchey III and IV diverticulitis

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2012-12
• Study Completion: 2013-11
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-18
• Last Update Posted: 2014-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Hartmann intervention	Surgery : Hartmann intervention
2	Protected anastomosis resection	Surgery : primary resection with anastomosis with protective stoma

Primary Outcome Measures

Name	Time	Method
Death rate comparison between two chirurgical strategies	18 months

Trial Locations

Locations (1)

CHU - Rouen; 🇫🇷 Rouen, France