Primary vs. Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis a Prospective Randomized Trial
DIVERTI
1 other identifier
interventional
102
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 3, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedApril 16, 2026
April 1, 2026
4.5 years
June 3, 2008
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Death rate comparison between two chirurgical strategies
18 months
Study Arms (2)
1
ACTIVE COMPARATORSurgery : Hartmann intervention
2
EXPERIMENTALSurgery : primary resection with anastomosis with protective stoma
Interventions
sigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma
Eligibility Criteria
You may qualify if:
- Patient with peritonitis du to sigmoid diverticulum complication
- Surgeon - anesthetist confirming the 2 surgeries can be performed
You may not qualify if:
- Physical state which can not permit patient to participate
- contraindication to surgery
- non-diverticulum peritonitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU - Rouen
Rouen, 76031, France
Related Publications (2)
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.
PMID: 29478474RESULTBridoux 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.
PMID: 28943323RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JJ TUECH, PhD
UH Rouen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2008
First Posted
June 6, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2012
Study Completion
November 1, 2013
Last Updated
April 16, 2026
Record last verified: 2026-04