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

Last updated: May 10, 2022
Sponsor: University Hospital, Rouen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Soft Tissue Infections

Intra-abdominal Infections

Treatment

N/A

Clinical Study ID

NCT04604730
2019/409/HP
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 withprimary anastomosis
  3. Person informed and having signed his consent. If the patient is unable to sign hisconsent, the consent will be signed by his representative ((1) the trusted person, orfailing that, (2) a family member, or (3) a relative of the person concerned) (ArticleL1122-1-1 of the CSP). In this case, consent to continue the study will subsequentlybe requested from the patient. --> In addition, due to the vital urgency representedby hospitalisation in intensive care for purulent or fecal peritonitis, inclusionwithout prior collection of the consent of the patient or his/her representative ispossible in the case where the patient is not capable of giving consent and his/herrepresentative 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 aspossible and his/her written consent will be requested for the possible continuationof 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:
  6. Physical states that prevent patient participation (e.g. septic shock or multivisceralfailure)
  7. Steroid treatment > 20 mg daily
  8. Prior pelvic irradiation
  9. Immunocompromised status
  10. Known progressive cancer
  11. American Society of Anesthesiologists grade IV
  12. Peritonitis secondary to perforated diverticulitis of the right colon
  13. Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating)woman or intending to become pregnant during the study
  14. Person deprived of liberty by administrative or judicial decision or placed underjudicial protection (guardianship or supervision)
  15. Simultaneous participation in another interventional research

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 204
Study Start date:
June 11, 2021
Estimated Completion Date:
June 01, 2026

Study 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

Connect with a study center

  • CHU Amiens

    Amiens,
    France

    Site Not Available

  • CH Beauvais

    Beauvais,
    France

    Site Not Available

  • CHU Besançon

    Besançon,
    France

    Site Not Available

  • APHP Avicenne

    Bobigny,
    France

    Site Not Available

  • CHU Brest

    Brest,
    France

    Site Not Available

  • CHU Caen

    Caen,
    France

    Site Not Available

  • CHU Clermont Ferrand

    Clermont-Ferrand,
    France

    Site Not Available

  • APHP Henri Mondor

    Créteil,
    France

    Site Not Available

  • CHU Grenoble

    Grenoble,
    France

    Site Not Available

  • CHU Limoges

    Limoges,
    France

    Site Not Available

  • CHU Lyon

    Lyon,
    France

    Site Not Available

  • APHM Hôpital Nord

    Marseille,
    France

    Site Not Available

  • APHM La Timone

    Marseille,
    France

    Site Not Available

  • CHU Nancy

    Nancy,
    France

    Site Not Available

  • CHU Nantes

    Nantes,
    France

    Site Not Available

  • CHU Nimes

    Nîmes,
    France

    Site Not Available

  • APHP St Antoine

    Paris,
    France

    Site Not Available

  • CHU Rouen

    Rouen,
    France

    Active - Recruiting

  • CHU Tours

    Tours,
    France

    Site Not Available

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