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CompletedNCT00692393DIVERTIUpdated Apr 16, 2026

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

An interventional study of Hartmann intervention and Protected anastomosis resection in Peritonitis, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

inclusion criteria: hinchey III and IV diverticulitis

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Conditions studied

  • Peritonitis

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03

In context

Peritonitis

167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.

This study's enrollment of 102 is above the median of 79 across 106 interventional studies indexed under Peritonitis.

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Lead sponsor

University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient with peritonitis du to sigmoid diverticulum complication
  • Surgeon - anesthetist confirming the 2 surgeries can be performed

Exclusion criteria

Exclusion Criteria:

  • Physical state which can not permit patient to participate
  • to surgery
  • non-diverticulum peritonitis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Active comparator
    1

    Surgery : Hartmann intervention

    Procedure: Hartmann intervention

  • Experimental
    2

    Surgery : primary resection with anastomosis with protective stoma

    Procedure: Protected anastomosis resection

Interventions

  • ProcedureHartmann intervention

    sigmoid resection, peritoneal and rectal lavage, terminal stoma

  • ProcedureProtected anastomosis resection

    sigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma

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What researchers measure

Primary outcomes

  1. Death rate comparison between two chirurgical strategies

    Time frame: 18 months

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Study locations

1 site
  • CHU - Rouen
    Rouen, 76031, France
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References and documents

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 29478474 ↗
  • 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. PubMed 28943323 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2008, a primary completion of Dec 2012 and a completion of Nov 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 3, 2008
First posted
Jun 6, 2008
Start
Jun 2008
Primary completionActual
Dec 2012
CompletionActual
Nov 2013
Last update
Apr 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00692393
Responsible party
Sponsor
First posted
Jun 6, 2008
Start date
Jun 2008
Primary completion
Dec 2012
Completion
Nov 2013
Last update
Apr 16, 2026

Study contacts

JJ TUECH, PhD
principal investigator · UH Rouen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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