Evaluating surgical options for treating peritonitis from perforated diverticulitis
Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis: a Prospective Multicenter Randomized Trial
NA · University Hospital, Rouen · NCT04604730
This study is testing two different surgical methods for treating peritonitis caused by perforated diverticulitis to see which one helps patients recover better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Rouen (other) |
| Locations | 20 sites (Beauvais, Beauvais and 19 other locations) |
| Trial ID | NCT04604730 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing surgery for purulent or fecal peritonitis due to perforated diverticulitis.
Not a fit: Patients with non-perforated diverticulitis or those who are not surgical candidates may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients with perforated diverticulitis.
How similar studies have performed: Previous studies have explored similar surgical strategies, indicating potential for success, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beauvais, Beauvais and 19 other locations
- CHR Beauvais — Beauvais, Beauvais, France (NOT_YET_RECRUITING)
- CHU Amiens — Amiens, France (RECRUITING)
- CH Beauvais — Beauvais, France (NOT_YET_RECRUITING)
- CHU Besançon — Besançon, France (NOT_YET_RECRUITING)
- APHP Avicenne — Bobigny, France (NOT_YET_RECRUITING)
- CHU Brest — Brest, France (RECRUITING)
- CHU Caen — Caen, France (NOT_YET_RECRUITING)
- CHU Clermont Ferrand — Clermont-Ferrand, France (NOT_YET_RECRUITING)
- APHP Henri Mondor — Créteil, France (NOT_YET_RECRUITING)
- CHU Grenoble — Grenoble, France (NOT_YET_RECRUITING)
- CHU Limoges — Limoges, France (NOT_YET_RECRUITING)
- CHU Lyon — Lyon, France (NOT_YET_RECRUITING)
- APHM Hôpital Nord — Marseille, France (RECRUITING)
- APHM La Timone — Marseille, France (RECRUITING)
- CHU Nancy — Nancy, France (NOT_YET_RECRUITING)
- CHU Nantes — Nantes, France (NOT_YET_RECRUITING)
- CHU Nimes — Nîmes, France (NOT_YET_RECRUITING)
- APHP St Antoine — Paris, France (NOT_YET_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peritonitis, peritonitis, perforated diverticulitis, primary anastomosis, protective stoma