Actively Recruiting
Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis
Led by University Hospital, Rouen · Updated on 2025-09-30
204
Participants Needed
20
Research Sites
285 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed to be a multicentre, prospective, comparative, randomised trial, evaluating the efficacy of two surgical strategies for the treatment of generalised peritonitis due to perforated diverticulitis. Results will be analysed according to an intention to treat principle (after selection and patient consent). Immediately before surgery, the patient will be randomly assigned to sigmoidectomy with primary anastomosis or to sigmoidectomy with primary anastomosis and diverting stoma. Sigmoidectomy will be performed through a midline laparotomy or laparoscopically according to the standard technique. In the control arm, a protective stoma will be performed at the end of surgery. A stoma reversal operation will be performed at least 3 months after the first operation and after performing a cologram by water soluble contrast between 4 and 8 weeks to check for the absence of fistula or stenosis at the level of the anastomosis. Stoma reversal will be performed with a trephine incision. Post-stoma closure follow-ups will be planned and all morbidity/mortality will be recorded. All patients will be examined at 6, 12, and 24 weeks after the initial surgery, in the surgical department where they were operated; a final study visit will be carried out 12 months (evaluation of primary endpoint) after surgery. The parameters explored at medical examinations will be: • Occurrence of complications • Quality of life assessment
CONDITIONS
Official Title
Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- 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
- Person informed and having signed consent, or consent signed by a representative if the patient is unable to sign
- Patients able to comply with study protocol as judged by the investigator
- Patient affiliated with or beneficiary of social security (health insurance)
You will not qualify if you...
- Physical conditions preventing patient participation (e.g., septic shock or multivisceral failure)
- Steroid treatment exceeding 20 mg daily
- Prior pelvic irradiation
- Immunocompromised status
- Known progressive cancer
- American Society of Anesthesiologists grade IV
- Peritonitis secondary to perforated diverticulitis of the right colon
- Pregnant, breastfeeding, or intending to become pregnant during the study
- Person deprived of liberty by administrative or judicial decision or under judicial protection
- Simultaneous participation in another interventional research
- Failure to obtain consent from patient or representative
AI-Screening
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Trial Site Locations
Total: 20 locations
1
CHR Beauvais
Beauvais, Beauvais, France, 60021
Not Yet Recruiting
2
CHU Amiens
Amiens, France
Actively Recruiting
3
CH Beauvais
Beauvais, France
Not Yet Recruiting
4
CHU Besançon
Besançon, France
Not Yet Recruiting
5
APHP Avicenne
Bobigny, France
Not Yet Recruiting
6
CHU Brest
Brest, France
Actively Recruiting
7
CHU Caen
Caen, France
Not Yet Recruiting
8
CHU Clermont Ferrand
Clermont-Ferrand, France
Not Yet Recruiting
9
APHP Henri Mondor
Créteil, France
Not Yet Recruiting
10
CHU Grenoble
Grenoble, France
Not Yet Recruiting
11
CHU Limoges
Limoges, France
Not Yet Recruiting
12
CHU Lyon
Lyon, France
Not Yet Recruiting
13
APHM Hôpital Nord
Marseille, France
Actively Recruiting
14
APHM La Timone
Marseille, France
Actively Recruiting
15
CHU Nancy
Nancy, France
Not Yet Recruiting
16
CHU Nantes
Nantes, France
Not Yet Recruiting
17
CHU Nimes
Nîmes, France
Not Yet Recruiting
18
APHP St Antoine
Paris, France
Not Yet Recruiting
19
CHU Rouen
Rouen, France
Actively Recruiting
20
CHU Tours
Tours, France
Actively Recruiting
Research Team
V
Valérie BRIDOUX, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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