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
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
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
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