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

NCT04604730 | Recruiting

• 2 other identifiers: 2019/0409/HP2020-A01538-31
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 20

Brief 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

Conditions

Peritonitis

Keywords

peritonitis; perforated diverticulitis; primary anastomosis; protective stoma

Outcome Measures

Primary Outcomes (1)

• Comparison of overall morbidity between "with protective stoma" and "without protective stoma"

  Overall morbidity graded 0 to 5 according to the Clavien-Dindo classification All complications occurring during hospitalization will be collected. Late complications occurring after hospitalization will be collected during follow-up.

  12 months posteoperatively

Secondary Outcomes (14)

• Comparison of the rate of death between "with protective stoma" and "without protective stoma"

  3 months postoperatively

• Comparison of the rate of reinterventions between "with protective stoma" and "without protective stoma"

  12 months postoperatively

• Comparison of the rate of incisional surgical site infection (SSI) between "with protective stoma" and "without protective stoma"

  12 months postoperatively

• Comparison of the rate of organ/space SSI between "with protective stoma" and "without protective stoma"

  12 months postoperatively

• Comparison of the rate of wound disruptions between "with protective stoma" and "without protective stoma"

  12 months postoperatively

Study Arms (2)

Primary anastomosis without protective stoma

EXPERIMENTAL

Primary anastomosis without protective stoma

Procedure: Primary anastomosis without protective stoma

Anastomosis with protective stoma

ACTIVE COMPARATOR

Anastomosis with protective stoma

Procedure: Anastomosis with protective stoma

Interventions

Primary anastomosis without protective stoma PROCEDURE

Primary anastomosis without protective stoma

Primary anastomosis without protective stoma

Anastomosis with protective stoma PROCEDURE

Anastomosis with protective stoma

Anastomosis with protective stoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• 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
• Patient able to comply with the study protocol, in the investigator's judgment
• Patient affiliated with, or beneficiary of a social security (health insurance) category
• Physical states that prevent patient participation (e.g. septic shock or multivisceral failure)
• Steroid treatment \> 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
• Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study
• Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
• Simultaneous participation in another interventional research

You may not qualify if:

• \. Failure to obtain the consent of the patient or the patient's representative

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (20)

CHR Beauvais

Beauvais, Beauvais, 60021, France

NOT YET RECRUITING

CHU Amiens

Amiens, France

RECRUITING

CH Beauvais

Beauvais, France

NOT YET RECRUITING

CHU Besançon

Besançon, France

NOT YET RECRUITING

APHP Avicenne

Bobigny, France

NOT YET RECRUITING

CHU Brest

Brest, France

RECRUITING

CHU Caen

Caen, France

NOT YET RECRUITING

CHU Clermont Ferrand

Clermont-Ferrand, France

NOT YET RECRUITING

APHP Henri Mondor

Créteil, France

NOT YET RECRUITING

CHU Grenoble

Grenoble, France

NOT YET RECRUITING

CHU Limoges

Limoges, France

NOT YET RECRUITING

CHU Lyon

Lyon, France

NOT YET RECRUITING

APHM Hôpital Nord

Marseille, France

RECRUITING

APHM La Timone

Marseille, France

RECRUITING

CHU Nancy

Nancy, France

NOT YET RECRUITING

CHU Nantes

Nantes, France

NOT YET RECRUITING

CHU Nimes

Nîmes, France

NOT YET RECRUITING

APHP St Antoine

Paris, France

NOT YET RECRUITING

CHU Rouen

Rouen, France

RECRUITING

CHU Tours

Tours, France

RECRUITING

Related Publications (1)

• Pinson J, Tuech JJ, Ouaissi M, Mathonnet M, Mauvais F, Houivet E, Lacroix E, Rondeaux J, Sabbagh C, Bridoux V. Role of protective stoma after primary anastomosis for generalized peritonitis due to perforated diverticulitis-DIVERTI 2 (a prospective multicenter randomized trial): rationale and design (nct04604730). BMC Surg. 2022 May 16;22(1):191. doi: 10.1186/s12893-022-01589-w.

  PMID: 35578267 DERIVED

MeSH Terms

Conditions

Peritonitis

Interventions

Anastomosis, Surgical

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Valérie BRIDOUX, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie BRIDOUX, Pr

CONTACT

02 32 88 81 42; valerie.bridoux@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential assignment

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 27, 2020
• Study Start: June 11, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (20)