Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis (DIVERTI2)

Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis: a Prospective Multicenter Randomized Trial

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

Study Overview

• Status: Recruiting
• Conditions: Peritonitis
• Intervention / Treatment: Procedure: Primary anastomosis without protective stoma; Procedure: Anastomosis with protective stoma

Detailed Description

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. The diagnosis will be established by the surgeon investigator on clinical data, imagery and operative findings during a laparotomy or laparoscopy. After selection and patient consent and 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, with lateral to medial mobilisation of the left colon, mobilisation of splenic flexure and identification of left ureter. The rectosigmoid junction will be exposed and transected with a stapler. Proximal section will be performed on a healthy colonic segment. The anastomosis will be performed according to the surgeon investigator's preference (mechanical or manual anastomosis; end to end or side to end).

Decisions to clean the colon intraoperatively and to place a drain will be left to the surgeon's discretion. 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

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valérie BRIDOUX, Pr; Phone Number: 02 32 88 81 42; Email: valerie.bridoux@chu-rouen.fr

Study Locations

• France
  • Amiens, France
    • Recruiting
    • CHU Amiens
    • Contact: Jean-Marc REGIMBEAU
    • Sub-Investigator: Jean-Marc REGIMBEAU
  • Beauvais, France
    • Not yet recruiting
    • CH Beauvais
    • Contact: François MAUVAIS
    • Sub-Investigator: François MAUVAIS
  • Besançon, France
    • Not yet recruiting
    • CHU Besançon
    • Contact: Zaher LAKKIS
    • Sub-Investigator: Zaher LAKKIS
  • Bobigny, France
    • Not yet recruiting
    • Aphp Avicenne
    • Contact: Christophe TRESALLET
    • Sub-Investigator: Christophe TRESALLET
  • Brest, France
    • Recruiting
    • CHU Brest
    • Contact: Bogdan BADIC
    • Sub-Investigator: Bogdan BADIC
  • Caen, France
    • Not yet recruiting
    • CHU Caen
    • Contact: Arnaud ALVES
    • Sub-Investigator: Arnaud ALVES
    • Sub-Investigator: Jean LUBRANO
  • Clermont-Ferrand, France
    • Not yet recruiting
    • Chu Clermont Ferrand
    • Contact: Anne DUBOIS
    • Sub-Investigator: Anne DUBOIS
  • Créteil, France
    • Not yet recruiting
    • APHP Henri Mondor
    • Contact: Nicolas DE'ANGELIS
    • Sub-Investigator: Nicolas DE'ANGELIS
  • Grenoble, France
    • Not yet recruiting
    • CHU Grenoble
    • Contact: Jean-Luc FAUCHERON
    • Sub-Investigator: Jean-Luc FAUCHERON
  • Limoges, France
    • Not yet recruiting
    • CHU Limoges
    • Contact: Muriel MATHONNET
    • Sub-Investigator: Muriel MATHONNET
  • Lyon, France
    • Not yet recruiting
    • CHU Lyon
    • Contact: Eddy COTTE
    • Sub-Investigator: Eddy COTTE
  • Marseille, France
    • Recruiting
    • APHM La Timone
    • Contact: Diane MEGE
    • Sub-Investigator: Diane MEGE
  • Marseille, France
    • Recruiting
    • APHM Hopital Nord
    • Contact: Laura BEYER BERJOT
    • Sub-Investigator: Laura BEYER BERJOT
  • Nancy, France
    • Not yet recruiting
    • CHU Nancy
    • Contact: Adeline GERMAIN
    • Sub-Investigator: Adeline Germain
  • Nantes, France
    • Not yet recruiting
    • CHU Nantes
    • Contact: Guillaume MEURETTE
    • Sub-Investigator: Guillaume MEURETTE
  • Nîmes, France
    • Not yet recruiting
    • CHU Nîmes
    • Contact: Michel PRUDHOMME
    • Sub-Investigator: Michel PRUDHOMME
  • Paris, France
    • Not yet recruiting
    • APHP St Antoine
    • Contact: Yann PARC
    • Sub-Investigator: Yann PARC
    • Sub-Investigator: Jeremie LEFEVRE
  • Rouen, France
    • Recruiting
    • CHU Rouen
    • Contact: Valérie BRIDOUX
    • Principal Investigator: Valérie BRIDOUX
  • Tours, France
    • Recruiting
    • CHU Tours
    • Contact: Mehdi OUAISSI
    • Sub-Investigator: Mehdi OUAISSI
  • Beauvais
    • Beauvais, Beauvais, France, 60021
      • Not yet recruiting
      • Chr Beauvais
      • Contact: Francois MAUVAIS, MD; Phone Number: 2626 +33 344 11; Email: f.mauvais@ch-beauvais.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. 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
3. Person informed and having signed his consent. If the patient is unable to sign his consent, the consent will be signed by his representative ((1) the trusted person, or failing that, (2) a family member, or (3) a relative of the person concerned) (Article L1122-1-1 of the CSP). In this case, consent to continue the study will subsequently be requested from the patient. --> In addition, due to the vital urgency represented by hospitalisation in intensive care for purulent or fecal peritonitis, inclusion without prior collection of the consent of the patient or his/her representative is possible in the case where the patient is not capable of giving consent and his/her representative is not present at the time of inclusion (Article L1122-1-3 of the CSP). In this case, the patient or his/her representative will be informed as soon as possible and his/her written consent will be requested for the possible continuation of this research and the use of the data concerning him/her.
4. Patient able to comply with the study protocol, in the investigator's judgment
5. Patient affiliated with, or beneficiary of a social security (health insurance) category

Non-inclusion Criteria:

1. Physical states that prevent patient participation (e.g. septic shock or multivisceral failure)
2. Steroid treatment > 20 mg daily
3. Prior pelvic irradiation
4. Immunocompromised status
5. Known progressive cancer
6. American Society of Anesthesiologists grade IV
7. Peritonitis secondary to perforated diverticulitis of the right colon
8. Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study
9. Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
10. Simultaneous participation in another interventional research

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary anastomosis without protective stoma	Procedure: Primary anastomosis without protective stoma; Primary anastomosis without protective stoma
Active Comparator: Anastomosis with protective stoma	Procedure: Anastomosis with protective stoma; Anastomosis with protective stoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the rate of death between "with protective stoma" and "without protective stoma"	rate of death at 3 months after surgery (%)	3 months postoperatively
Comparison of the rate of reinterventions between "with protective stoma" and "without protective stoma"	the rate of reinterventions after the surgery (%)	12 months postoperatively
Comparison of the rate of incisional surgical site infection (SSI) between "with protective stoma" and "without protective stoma"	the rate of incisional SSI (%)	12 months postoperatively
Comparison of the rate of organ/space SSI between "with protective stoma" and "without protective stoma"	the rate of organ/space SSI (%)	12 months postoperatively
Comparison of the rate of wound disruptions between "with protective stoma" and "without protective stoma"	the rate of wound disruptions (%)	12 months postoperatively
Comparison of the rate of anastomotic leaks between "with protective stoma" and "without protective stoma"	the rate of anastomotic leaks (%)	12 months postoperatively
Comparison of operating time between "with protective stoma" and "without protective stoma"	time of surgery (hours)	surgery
Comparison of length of postoperative hospital stay between "with protective stoma" and "without protective stoma"	Length of postoperative hospital stay (days)	6 months postoperatively
Comparison of Intensive Care Unit (ICU) length of stay between "with protective stoma" and "without protective stoma"	ICU length of stay (days)	6 months postoperatively
Comparison of the number of patients alive without stoma between "with protective stoma" and "without protective stoma"	Number of patients alive without stoma at 12 months after initial surgery	12 months after initial surgery
Comparison of the quality of life between "with protective stoma" and "without protective stoma"	Quality of life evaluated using the Short Form Health Survey (SF-36) questionnaire at baseline, 6, 12, 26 and 52 weeks after primary surgery Score from 1 to 30	6, 12, 26 and 52 weeks after primary surgery
Comparison of the quality of life between "with protective stoma" and "without protective stoma" with "EuroQol-5 Dimensions" questionnaire	Quality of life evaluated using EuroQol-5 Dimensions (EQ-5D) questionnaire at baseline, 6, 12, 26 and 52 weeks after primary surgery Each dimension has three levels of response: no problems (coded 1), some problems (coded 2) and major problems (coded 3), which defines 243 possible health states (35), to which can be added unconscious and dead states, for a total of 245 states. Thus, the health states range from "11111" (no problems on all dimensions) to "33333": major problems on all dimensions + visual analog scale from 0 to 100, 0 being the worst and 100 the best	6, 12, 26 and 52 weeks after primary surgery
Comparison of the quality of life between "with protective stoma" and "without protective stoma" with the Gastrintestinal Quality of Life Index questionnaire	Quality of life evaluated using Ethe Gastrintestinal Quality of Life Index questionnaire at baseline, 6, 12, 26 and 52 weeks after primary surgery Score from 0 to 144, the higher the score, the better the quality of life	6, 12, 26 and 52 weeks after primary surgery
Comparison of the cost utility between "with protective stoma" and "without protective stoma"	Quality-Adjusted Life Year (QALY) derived from the EQ5D-5L questionnaire	12 months after primary surgery

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Valérie BRIDOUX, Pr, University Hospital, Rouen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: peritonitis; perforated diverticulitis; primary anastomosis; protective stoma
• Additional Relevant MeSH Terms: Infections; Digestive System Diseases; Peritoneal Diseases; Intraabdominal Infections; Peritonitis; Surgical Procedures, Operative; Anastomosis, Surgical
• Other Study ID Numbers: 2019/0409/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No