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

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ClinicalTrials.gov Identifier: NCT00692393
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : June 19, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Peritonitis Procedure: Hartmann intervention Procedure: Protected anastomosis resection

Detailed Description:
inclusion criteria: hinchey III and IV diverticulitis

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Primary vs. Secondary Anastomosis After Sigmoid Colon Resection for Perforated Diverticulitis (Hinchey Stage III and IV): a Prospective Multicentric Randomized Trial
Study Start Date : June 2008
Primary Completion Date : December 2012
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Surgery : Hartmann intervention
Procedure: Hartmann intervention
sigmoid resection, peritoneal and rectal lavage, terminal stoma
Experimental: 2
Surgery : primary resection with anastomosis with protective stoma
Procedure: Protected anastomosis resection
sigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma



Primary Outcome Measures :
  1. Death rate comparison between two chirurgical strategies [ Time Frame: 18 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692393


Locations
France
CHU - Rouen
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: JJ TUECH, PhD UH Rouen

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00692393     History of Changes
Other Study ID Numbers: 2006/103/HP
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: June 19, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Peritonitis
Diverticulitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases