Evaluating surgical options for treating peritonitis from perforated diverticulitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicentre, prospective, comparative, randomised trial aims to assess the effectiveness of two surgical approaches for managing generalized peritonitis caused by perforated diverticulitis. Patients will be randomly assigned to undergo either sigmoidectomy with primary anastomosis or sigmoidectomy with primary anastomosis and a protective stoma. The study will analyze outcomes based on an intention to treat principle, with follow-up including a stoma reversal operation at least three months post-surgery. The surgical procedures will be performed using standard techniques, with decisions regarding intraoperative management left to the surgeon's discretion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years
2. Patients operated for purulent or fecal peritonitis (Hinchey grade III and IV) secondary to perforated diverticulitis of the left colon and treated by resection with primary anastomosis
3. Person informed and having signed his consent. If the patient is unable to sign his consent, the consent will be signed by his representative ((1) the trusted person, or failing that, (2) a family member, or (3) a relative of the person concerned) (Article L1122-1-1 of the CSP). In this case, consent to continue the study will subsequently be requested from the patient. --\> In addition, due to the vital urgency represented by hospitalisation in intensive care for purulent or fecal peritonitis, inclusion without prior collection of the consent of the patient or his/her representative is possible in the case where the patient is not capable of giving consent and his/her representative is not present at the time of inclusion (Article L1122-1-3 of the CSP). In this case, the patient or his/her representative will be informed as soon as possible and his/her written consent will be requested for the possible continuation of this research and the use of the data concerning him/her.
4. Patient able to comply with the study protocol, in the investigator's judgment
5. Patient affiliated with, or beneficiary of a social security (health insurance) category

Non-inclusion Criteria:

1. Physical states that prevent patient participation (e.g. septic shock or multivisceral failure)
2. Steroid treatment \> 20 mg daily
3. Prior pelvic irradiation
4. Immunocompromised status
5. Known progressive cancer
6. American Society of Anesthesiologists grade IV
7. Peritonitis secondary to perforated diverticulitis of the right colon
8. Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study
9. Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
10. Simultaneous participation in another interventional research

Exclusion Criteria:

1\. Failure to obtain the consent of the patient or the patient's representative

Where it's running

• CHU Amiens
  Amiens, France Recruiting
• CHU Brest
  Brest, France Recruiting
• APHM Hôpital Nord
  Marseille, France Recruiting
• APHM La Timone
  Marseille, France Recruiting
• CHU Rouen
  Rouen, France Recruiting
• CHU Tours
  Tours, France Recruiting

Study contacts

• Principal investigator: Valérie BRIDOUX, Pr — University Hospital, Rouen
• Study coordinator: Valérie BRIDOUX, Pr
• Email: valerie.bridoux@chu-rouen.fr
• Phone: 02 32 88 81 42

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AIDE: Decision Support for Emergency Surgery in Complicated Diverticulitis

  This observational study collects real-world data from adults undergoing emergency surgery for complicated diverticulitis to see how decisions between primary anastomosis and Hartmann’s procedure are made.

  Recruiting IRCCS San Raffaele Roma · Novedrate, Como and 1 other locations · NCT07651072

• Comparing vacuum assisted closure and on-demand relaparotomy for fecal peritonitis

  This study is testing whether using vacuum assisted closure or doing surgery as needed is better for patients with fecal peritonitis in terms of recovery and complications.

  Recruiting Odense University Hospital · Odense, Fyn · NCT03932461

• Personalized treatment with Pentaglobin® for patients with peritonitis after surgery

  This study is testing if adding Pentaglobin® to standard care can help patients recover better from peritonitis after surgery.

  Recruiting at 12 sites Phase 2 RWTH Aachen University · Vienna and 19 other locations · NCT03334006

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.