Back to resultsPrimary vs. Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis a Prospective Randomized Trial (DIVERTI)
Primary Purpose
Peritonitis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hartmann intervention
Protected anastomosis resection
Sponsored by
About this trial
This is an interventional treatment trial for Peritonitis
Eligibility 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
Sites / Locations
- CHU - Rouen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Surgery : Hartmann intervention
Surgery : primary resection with anastomosis with protective stoma
Outcomes
Primary Outcome Measures
Death rate comparison between two chirurgical strategies
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00692393
Brief Title
Primary vs. Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis a Prospective Randomized Trial
Acronym
DIVERTI
Official Title
Primary vs. Secondary Anastomosis After Sigmoid Colon Resection for Perforated Diverticulitis (Hinchey Stage III and IV): a Prospective Multicentric Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Surgery : Hartmann intervention
Arm Title
2
Arm Type
Experimental
Arm Description
Surgery : primary resection with anastomosis with protective stoma
Intervention Type
Procedure
Intervention Name(s)
Hartmann intervention
Intervention Description
sigmoid resection, peritoneal and rectal lavage, terminal stoma
Intervention Type
Procedure
Intervention Name(s)
Protected anastomosis resection
Intervention Description
sigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma
Primary Outcome Measure Information:
Title
Death rate comparison between two chirurgical strategies
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JJ TUECH, PhD
Organizational Affiliation
UH Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU - Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
Learn more about this trial
Primary vs. Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis a Prospective Randomized Trial
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