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

NCT ID: NCT00692393

Last Updated: 2014-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2013-11-30

Brief Summary

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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

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inclusion criteria: hinchey III and IV diverticulitis

Conditions

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Peritonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Surgery : Hartmann intervention

Group Type ACTIVE_COMPARATOR

Hartmann intervention

Intervention Type PROCEDURE

sigmoid resection, peritoneal and rectal lavage, terminal stoma

2

Surgery : primary resection with anastomosis with protective stoma

Group Type EXPERIMENTAL

Protected anastomosis resection

Intervention Type PROCEDURE

sigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma

Interventions

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Hartmann intervention

sigmoid resection, peritoneal and rectal lavage, terminal stoma

Intervention Type PROCEDURE

Protected anastomosis resection

sigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JJ TUECH, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Rouen

Locations

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CHU - Rouen

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2006/103/HP

Identifier Type: -

Identifier Source: org_study_id

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