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

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

Sponsors

Lead Sponsor: University Hospital, Rouen

Source University Hospital, Rouen
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

Overall Status Recruiting
Start Date 2021-06-11
Completion Date 2026-06-01
Primary Completion Date 2025-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Comparison of overall morbidity between "with protective stoma" and "without protective stoma" 12 months posteoperatively
Secondary Outcome
Measure Time Frame
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
Comparison of the rate of anastomotic leaks between "with protective stoma" and "without protective stoma" 12 months postoperatively
Comparison of operating time between "with protective stoma" and "without protective stoma" surgery
Comparison of length of postoperative hospital stay between "with protective stoma" and "without protective stoma" 6 months postoperatively
Comparison of Intensive Care Unit (ICU) length of stay between "with protective stoma" and "without protective stoma" 6 months postoperatively
Comparison of the number of patients alive without stoma between "with protective stoma" and "without protective stoma" 12 months after initial surgery
Comparison of the quality of life between "with protective stoma" and "without protective stoma" 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 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 6, 12, 26 and 52 weeks after primary surgery
Comparison of the cost utility between "with protective stoma" and "without protective stoma" 12 months after primary surgery
Enrollment 204
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Primary anastomosis without protective stoma

Description: Primary anastomosis without protective stoma

Arm Group Label: Primary anastomosis without protective stoma

Intervention Type: Procedure

Intervention Name: Anastomosis with protective stoma

Description: Anastomosis with protective stoma

Arm Group Label: Anastomosis with protective stoma

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Valérie BRIDOUX

Phone: 02 32 88 81 42

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
CHU Amiens | Amiens, France Not yet recruiting Jean-Marc REGIMBEAU Jean-Marc REGIMBEAU Sub-Investigator
CH Beauvais | Beauvais, France Not yet recruiting François MAUVAIS François MAUVAIS Sub-Investigator
CHU Besançon | Besançon, France Not yet recruiting Zaher LAKKIS Zaher LAKKIS Sub-Investigator
APHP Avicenne | Bobigny, France Not yet recruiting Christophe TRESALLET Christophe TRESALLET Sub-Investigator
CHU Brest | Brest, France Not yet recruiting Bogdan BADIC Bogdan BADIC Sub-Investigator
CHU Caen | Caen, France Not yet recruiting Arnaud ALVES Arnaud ALVES Sub-Investigator Jean LUBRANO Sub-Investigator
CHU Clermont Ferrand | Clermont-Ferrand, France Not yet recruiting Anne DUBOIS Anne DUBOIS Sub-Investigator
APHP Henri Mondor | Créteil, France Not yet recruiting Nicolas DE'ANGELIS Nicolas DE'ANGELIS Sub-Investigator
CHU Grenoble | Grenoble, France Not yet recruiting Jean-Luc FAUCHERON Jean-Luc FAUCHERON Sub-Investigator
CHU Limoges | Limoges, France Not yet recruiting Muriel MATHONNET Muriel MATHONNET Sub-Investigator
CHU Lyon | Lyon, France Not yet recruiting Eddy COTTE Eddy COTTE Sub-Investigator
APHM Hôpital Nord | Marseille, France Not yet recruiting Laura BEYER BERJOT Laura BEYER BERJOT Sub-Investigator
APHM La Timone | Marseille, France Not yet recruiting Diane MEGE Diane MEGE Sub-Investigator
CHU Nancy | Nancy, France Not yet recruiting Adeline GERMAIN Adeline GERMAIN Sub-Investigator
CHU Nantes | Nantes, France Not yet recruiting Guillaume MEURETTE Guillaume MEURETTE Sub-Investigator
CHU Nimes | Nîmes, France Not yet recruiting Michel PRUDHOMME Michel PRUDHOMME Sub-Investigator
APHP St Antoine | Paris, France Not yet recruiting Yann PARC Yann PARC Sub-Investigator Jeremie LEFEVRE Sub-Investigator
CHU Rouen | Rouen, France Recruiting Valérie BRIDOUX Valérie BRIDOUX Principal Investigator
CHU Tours | Tours, France Not yet recruiting Mehdi OUAISSI Mehdi OUAISSI Sub-Investigator
Location Countries

France

Verification Date

2020-10-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Primary anastomosis without protective stoma

Type: Experimental

Description: Primary anastomosis without protective stoma

Label: Anastomosis with protective stoma

Type: Active Comparator

Description: Anastomosis with protective stoma

Acronym DIVERTI 2
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Sequential assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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