search
Back to results

Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis (DIVERTI 2)

Primary Purpose

Peritonitis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Primary anastomosis without protective stoma
Anastomosis with protective stoma
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritonitis focused on measuring peritonitis, perforated diverticulitis, primary anastomosis, protective stoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens
  • CH Beauvais
  • CHU Besançon
  • APHP Avicenne
  • CHU Brest
  • CHU Caen
  • CHU Clermont Ferrand
  • APHP Henri Mondor
  • CHU Grenoble
  • CHU Limoges
  • CHU Lyon
  • APHM Hôpital Nord
  • APHM La Timone
  • CHU Nancy
  • CHU Nantes
  • CHU Nimes
  • APHP St Antoine
  • CHU RouenRecruiting
  • CHU Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Primary anastomosis without protective stoma

Anastomosis with protective stoma

Arm Description

Primary anastomosis without protective stoma

Anastomosis with protective stoma

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Comparison of the rate of death between "with protective stoma" and "without protective stoma"
rate of death at 3 months after surgery (%)
Comparison of the rate of reinterventions between "with protective stoma" and "without protective stoma"
the rate of reinterventions after the surgery (%)
Comparison of the rate of incisional surgical site infection (SSI) between "with protective stoma" and "without protective stoma"
the rate of incisional SSI (%)
Comparison of the rate of organ/space SSI between "with protective stoma" and "without protective stoma"
the rate of organ/space SSI (%)
Comparison of the rate of wound disruptions between "with protective stoma" and "without protective stoma"
the rate of wound disruptions (%)
Comparison of the rate of anastomotic leaks between "with protective stoma" and "without protective stoma"
the rate of anastomotic leaks (%)
Comparison of operating time between "with protective stoma" and "without protective stoma"
time of surgery (hours)
Comparison of length of postoperative hospital stay between "with protective stoma" and "without protective stoma"
Length of postoperative hospital stay (days)
Comparison of Intensive Care Unit (ICU) length of stay between "with protective stoma" and "without protective stoma"
ICU length of stay (days)
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
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
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
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
Comparison of the cost utility between "with protective stoma" and "without protective stoma"
Quality-Adjusted Life Year (QALY) derived from the EQ5D-5L questionnaire

Full Information

First Posted
October 15, 2020
Last Updated
May 10, 2022
Sponsor
University Hospital, Rouen
search

1. Study Identification

Unique Protocol Identification Number
NCT04604730
Brief Title
Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis
Acronym
DIVERTI 2
Official Title
Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis: a Prospective Multicenter Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonitis
Keywords
peritonitis, perforated diverticulitis, primary anastomosis, protective stoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sequential assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary anastomosis without protective stoma
Arm Type
Experimental
Arm Description
Primary anastomosis without protective stoma
Arm Title
Anastomosis with protective stoma
Arm Type
Active Comparator
Arm Description
Anastomosis with protective stoma
Intervention Type
Procedure
Intervention Name(s)
Primary anastomosis without protective stoma
Intervention Description
Primary anastomosis without protective stoma
Intervention Type
Procedure
Intervention Name(s)
Anastomosis with protective stoma
Intervention Description
Anastomosis with protective stoma
Primary Outcome Measure Information:
Title
Comparison of overall morbidity between "with protective stoma" and "without protective stoma"
Description
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.
Time Frame
12 months posteoperatively
Secondary Outcome Measure Information:
Title
Comparison of the rate of death between "with protective stoma" and "without protective stoma"
Description
rate of death at 3 months after surgery (%)
Time Frame
3 months postoperatively
Title
Comparison of the rate of reinterventions between "with protective stoma" and "without protective stoma"
Description
the rate of reinterventions after the surgery (%)
Time Frame
12 months postoperatively
Title
Comparison of the rate of incisional surgical site infection (SSI) between "with protective stoma" and "without protective stoma"
Description
the rate of incisional SSI (%)
Time Frame
12 months postoperatively
Title
Comparison of the rate of organ/space SSI between "with protective stoma" and "without protective stoma"
Description
the rate of organ/space SSI (%)
Time Frame
12 months postoperatively
Title
Comparison of the rate of wound disruptions between "with protective stoma" and "without protective stoma"
Description
the rate of wound disruptions (%)
Time Frame
12 months postoperatively
Title
Comparison of the rate of anastomotic leaks between "with protective stoma" and "without protective stoma"
Description
the rate of anastomotic leaks (%)
Time Frame
12 months postoperatively
Title
Comparison of operating time between "with protective stoma" and "without protective stoma"
Description
time of surgery (hours)
Time Frame
surgery
Title
Comparison of length of postoperative hospital stay between "with protective stoma" and "without protective stoma"
Description
Length of postoperative hospital stay (days)
Time Frame
6 months postoperatively
Title
Comparison of Intensive Care Unit (ICU) length of stay between "with protective stoma" and "without protective stoma"
Description
ICU length of stay (days)
Time Frame
6 months postoperatively
Title
Comparison of the number of patients alive without stoma between "with protective stoma" and "without protective stoma"
Description
Number of patients alive without stoma at 12 months after initial surgery
Time Frame
12 months after initial surgery
Title
Comparison of the quality of life between "with protective stoma" and "without protective stoma"
Description
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
Time Frame
6, 12, 26 and 52 weeks after primary surgery
Title
Comparison of the quality of life between "with protective stoma" and "without protective stoma" with "EuroQol-5 Dimensions" questionnaire
Description
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
Time Frame
6, 12, 26 and 52 weeks after primary surgery
Title
Comparison of the quality of life between "with protective stoma" and "without protective stoma" with the Gastrintestinal Quality of Life Index questionnaire
Description
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
Time Frame
6, 12, 26 and 52 weeks after primary surgery
Title
Comparison of the cost utility between "with protective stoma" and "without protective stoma"
Description
Quality-Adjusted Life Year (QALY) derived from the EQ5D-5L questionnaire
Time Frame
12 months after primary surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. 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 Non-inclusion Criteria: 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 Exclusion Criteria: 1. Failure to obtain the consent of the patient or the patient's representative
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie BRIDOUX, Pr
Phone
02 32 88 81 42
Email
valerie.bridoux@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie BRIDOUX, Pr
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc REGIMBEAU
First Name & Middle Initial & Last Name & Degree
Jean-Marc REGIMBEAU
Facility Name
CH Beauvais
City
Beauvais
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François MAUVAIS
First Name & Middle Initial & Last Name & Degree
François MAUVAIS
Facility Name
CHU Besançon
City
Besançon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaher LAKKIS
First Name & Middle Initial & Last Name & Degree
Zaher LAKKIS
Facility Name
APHP Avicenne
City
Bobigny
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe TRESALLET
First Name & Middle Initial & Last Name & Degree
Christophe TRESALLET
Facility Name
CHU Brest
City
Brest
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bogdan BADIC
First Name & Middle Initial & Last Name & Degree
Bogdan BADIC
Facility Name
CHU Caen
City
Caen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud ALVES
First Name & Middle Initial & Last Name & Degree
Arnaud ALVES
First Name & Middle Initial & Last Name & Degree
Jean LUBRANO
Facility Name
CHU Clermont Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne DUBOIS
First Name & Middle Initial & Last Name & Degree
Anne DUBOIS
Facility Name
APHP Henri Mondor
City
Créteil
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas DE'ANGELIS
First Name & Middle Initial & Last Name & Degree
Nicolas DE'ANGELIS
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc FAUCHERON
First Name & Middle Initial & Last Name & Degree
Jean-Luc FAUCHERON
Facility Name
CHU Limoges
City
Limoges
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muriel MATHONNET
First Name & Middle Initial & Last Name & Degree
Muriel MATHONNET
Facility Name
CHU Lyon
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eddy COTTE
First Name & Middle Initial & Last Name & Degree
Eddy COTTE
Facility Name
APHM Hôpital Nord
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura BEYER BERJOT
First Name & Middle Initial & Last Name & Degree
Laura BEYER BERJOT
Facility Name
APHM La Timone
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane MEGE
First Name & Middle Initial & Last Name & Degree
Diane MEGE
Facility Name
CHU Nancy
City
Nancy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adeline GERMAIN
First Name & Middle Initial & Last Name & Degree
Adeline GERMAIN
Facility Name
CHU Nantes
City
Nantes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume MEURETTE
First Name & Middle Initial & Last Name & Degree
Guillaume MEURETTE
Facility Name
CHU Nimes
City
Nîmes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel PRUDHOMME
First Name & Middle Initial & Last Name & Degree
Michel PRUDHOMME
Facility Name
APHP St Antoine
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yann PARC
First Name & Middle Initial & Last Name & Degree
Yann PARC
First Name & Middle Initial & Last Name & Degree
Jeremie LEFEVRE
Facility Name
CHU Rouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie BRIDOUX
First Name & Middle Initial & Last Name & Degree
Valérie BRIDOUX
Facility Name
CHU Tours
City
Tours
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehdi OUAISSI
First Name & Middle Initial & Last Name & Degree
Mehdi OUAISSI

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35578267
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs