Actively Recruiting
Led by University Hospital, Rouen · Updated on 2026-06-08
204
Participants Needed
20
Research Sites
13 weeks
Total Duration
Researchers are evaluating two surgical methods for treating generalized peritonitis caused by perforated diverticulitis, a serious abdominal infection. This prospective, multicenter, randomized trial compares sigmoidectomy with primary anastomosis alone to sigmoidectomy with primary anastomosis plus a protective stoma. The study analyzes outcomes based on an intention-to-treat approach to determine which strategy may better manage complications and improve quality of life. Patients will undergo sigmoidectomy via midline laparotomy or laparoscopy following standard surgical techniques. Those assigned to the control group will receive a protective stoma, which is a temporary opening to divert waste. This stoma, if placed, will be reversed at least three months after the initial surgery following imaging to ensure healing. Both groups will be followed after surgery to monitor complications and recovery. Participants will have follow-up visits at 6, 12, and 24 weeks after surgery and a final evaluation at 12 months. During these visits, doctors will assess complications and quality of life using specific questionnaires. The trial will record morbidity, mortality, reinterventions, infections, hospital stay lengths, and survival without stoma. This comprehensive monitoring aims to gather detailed information on the effects and outcomes of the two surgical strategies.
CONDITIONS
Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay until discharge
Participants undergo sigmoidectomy with primary anastomosis, with or without protective stoma based on random assignment. Surgery may be performed through laparotomy or laparoscopy. Post-surgery care begins immediately after the operation.
1 visit (in-person surgery and immediate post-operative care)
Duration - Up to 24 weeks after surgery
Participants are examined at 6, 12, and 24 weeks after the initial surgery to monitor complications and quality of life.
3 visits (in-person at 6, 12, and 24 weeks)
Duration - Surgery at least 3 months after initial surgery
For participants with protective stoma, a stoma reversal surgery is performed at least 3 months after the initial surgery following a cologram to check the anastomosis.
1 visit (in-person stoma reversal surgery)
Duration - Up to 12 months after initial surgery
Participants who had stoma reversal are followed up to record morbidity and mortality related to the procedure.
Visits planned after stoma closure as needed
Duration - 12 months after initial surgery
All participants complete a final evaluation at 12 months after surgery to assess overall morbidity and quality of life.
1 visit (in-person final assessment)
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
V
Valérie BRIDOUX, Pr
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Jean Pinson, Jean-Jacques Tuech, Mehdi Ouaissi...
https://pubmed.ncbi.nlm.nih.gov/35578267