- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00692393
Primary vs. Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis a Prospective Randomized Trial (DIVERTI)
April 13, 2026 updated by: University Hospital, Rouen
Primary vs. Secondary Anastomosis After Sigmoid Colon Resection for Perforated Diverticulitis (Hinchey Stage III and IV): a Prospective Multicentric Randomized Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
inclusion criteria: hinchey III and IV diverticulitis
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rouen, France, 76031
- CHU - Rouen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Surgery : Hartmann intervention
|
sigmoid resection, peritoneal and rectal lavage, terminal stoma
|
|
Experimental: 2
Surgery : primary resection with anastomosis with protective stoma
|
sigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Death rate comparison between two chirurgical strategies
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: JJ TUECH, PhD, UH Rouen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tuech JJ, Bridoux V. Randomized Clinical Trial (DIVERTI) and Ethical Considerations: In reply to Fujita. J Am Coll Surg. 2018 Mar;226(3):336-337. doi: 10.1016/j.jamcollsurg.2017.12.006. No abstract available.
- Bridoux V, Regimbeau JM, Ouaissi M, Mathonnet M, Mauvais F, Houivet E, Schwarz L, Mege D, Sielezneff I, Sabbagh C, Tuech JJ. Hartmann's Procedure or Primary Anastomosis for Generalized Peritonitis due to Perforated Diverticulitis: A Prospective Multicenter Randomized Trial (DIVERTI). J Am Coll Surg. 2017 Dec;225(6):798-805. doi: 10.1016/j.jamcollsurg.2017.09.004. Epub 2017 Sep 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
June 3, 2008
First Submitted That Met QC Criteria
June 5, 2008
First Posted (Estimated)
June 6, 2008
Study Record Updates
Last Update Posted (Actual)
April 16, 2026
Last Update Submitted That Met QC Criteria
April 13, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006/103/HP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.