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

University Hospital, Rouen

Status: Completed

Conditions: Peritonitis

Treatments: Procedure: Protected anastomosis resection; Procedure: Hartmann intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00692393

2006/103/HP

Details and patient eligibility

About

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.

Full description

inclusion criteria: hinchey III and IV diverticulitis

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

1

Active Comparator group

Description:

Surgery : Hartmann intervention

Treatment:

Procedure: Hartmann intervention

2

Experimental group

Description:

Surgery : primary resection with anastomosis with protective stoma

Treatment:

Procedure: Protected anastomosis resection