Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04604730

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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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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