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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00692393
First received: June 3, 2008
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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 Intervention
Peritonitis
Procedure: Hartmann intervention
Procedure: Protected anastomosis resection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Death rate comparison between two chirurgical strategies [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 102
Study Start Date: June 2008
Study Completion Date: November 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

inclusion criteria: hinchey III and IV diverticulitis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00692393

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

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00692393     History of Changes
Other Study ID Numbers: 2006/103/HP
Study First Received: June 3, 2008
Last Updated: June 18, 2014
Health Authority: France: Direction Générale de la Santé

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

ClinicalTrials.gov processed this record on July 26, 2014