PeritonitisDIVERTINCT00692393
Primary vs. Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis a Prospective Randomized Trial
A study testing Hartmann intervention and Protected anastomosis resection in people with Peritonitis, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritonitis
- What is being tested?
- Hartmann intervention and Protected anastomosis resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with peritonitis du to sigmoid diverticulum complication
- Surgeon - anesthetist confirming the 2 surgeries can be performed
Who cannot join
- Physical state which can not permit patient to participate
- contraindication to surgery
- non-diverticulum peritonitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
inclusion criteria: hinchey III and IV diverticulitis
- Conditions
- Peritonitis
- Being tested
- Hartmann intervention, Protected anastomosis resection
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hartmann interventionProcedure or surgery
sigmoid resection, peritoneal and rectal lavage, terminal stoma
Protected anastomosis resectionProcedure or surgery
sigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Surgery : Hartmann intervention Receives: Procedure: Hartmann intervention |
| 2 | Experimental | Surgery : primary resection with anastomosis with protective stoma Receives: Procedure: Protected anastomosis resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death rate comparison between two chirurgical strategies
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JJ TUECH, PhD, Principal investigator, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692393
- Sponsor's protocol ID
- 2006/103/HP
- Acronym
- DIVERTI
- Status last verified
- Apr 2026
- First submitted
- 3 Jun 2008
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29478474Bridoux 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.
PubMed 28943323
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary vs. Secondary Anastomosis After Sigmoid Colon Resection for Perforated Diverticulitis (Hinchey Stage III and IV): a Prospective Multicentric Randomized Trial
- ClinicalTrials.gov ID
- NCT00692393
- Acronym / sponsor ID
- DIVERTI / 2006/103/HP
- Conditions
- Peritonitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Hartmann interventionSurgery : Hartmann intervention |
| 2 | Experimental | Procedure: Protected anastomosis resectionSurgery : primary resection with anastomosis with protective stoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with peritonitis du to sigmoid diverticulum complication
- Surgeon - anesthetist confirming the 2 surgeries can be performed
Key exclusion criteria (3 listed)
- Physical state which can not permit patient to participate
- contraindication to surgery
- non-diverticulum peritonitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hartmann interventionsigmoid resection, peritoneal and rectal lavage, terminal stoma | Procedure or surgery | 1 |
| Protected anastomosis resectionsigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma | Procedure or surgery | 2 |
Primary outcome
Death rate comparison between two chirurgical strategies
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication: PubMed 29478474Tuech 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.
- Results publication: PubMed 28943323Bridoux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JJ TUECH, PhD principal investigator
UH Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hartmann intervention and Protected anastomosis resection in people with Peritonitis, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death rate comparison between two chirurgical strategies (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00692393, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.