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Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis
Sponsor: University Hospital, Rouen
Summary
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
Official title: Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis: a Prospective Multicenter Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
204
Start Date
2021-06-11
Completion Date
2026-12-01
Last Updated
2025-09-30
Healthy Volunteers
No
Conditions
Interventions
Primary anastomosis without protective stoma
Primary anastomosis without protective stoma
Anastomosis with protective stoma
Anastomosis with protective stoma
Locations (20)
CHR Beauvais
Beauvais, Beauvais, France
CHU Amiens
Amiens, France
CH Beauvais
Beauvais, France
CHU Besançon
Besançon, France
APHP Avicenne
Bobigny, France
CHU Brest
Brest, France
CHU Caen
Caen, France
CHU Clermont Ferrand
Clermont-Ferrand, France
APHP Henri Mondor
Créteil, France
CHU Grenoble
Grenoble, France
CHU Limoges
Limoges, France
CHU Lyon
Lyon, France
APHM Hôpital Nord
Marseille, France
APHM La Timone
Marseille, France
CHU Nancy
Nancy, France
CHU Nantes
Nantes, France
CHU Nimes
Nîmes, France
APHP St Antoine
Paris, France
CHU Rouen
Rouen, France
CHU Tours
Tours, France