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

Launched by UNIVERSITY HOSPITAL, ROUEN · Oct 21, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating the best surgical approach for treating generalized peritonitis, which is a serious condition caused by an infection in the abdomen due to perforated diverticulitis (a condition where pouches in the colon become inflamed or infected). The study will compare two surgical methods: one involving an anastomosis, where the surgeon reconnects the intestine after removing the affected part, and the other also includes a protective stoma, which is a temporary opening in the abdomen to allow waste to exit. Participants will be randomly assigned to one of these two groups right before surgery and will be monitored for complications and quality of life at various follow-up visits after their initial surgery.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with severe peritonitis due to perforated diverticulitis. They should also be able to understand the study and give consent, or have a representative provide consent if they are unable to do so. Throughout the trial, participants can expect thorough follow-up care, including assessments of any complications and how the surgery impacts their daily lives. This study aims to help determine the most effective treatment for this serious condition and improve outcomes for patients facing similar health challenges.

Gender

ALL

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