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RECRUITING
NCT04604730
NA

Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis

Sponsor: University Hospital, Rouen

View on ClinicalTrials.gov

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

PROCEDURE

Primary anastomosis without protective stoma

Primary anastomosis without protective stoma

PROCEDURE

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