An interventional study of Primary anastomosis without protective stoma and Anastomosis with protective stoma in Peritonitis, sponsored by University Hospital, Rouen. Recruiting at 20 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Treatment
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
167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.
This study's planned enrollment of 204 is above the median of 79 across 106 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Non-inclusion Criteria:
Exclusion Criteria:
1. Failure to obtain the consent of the patient or the patient's representative
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Primary anastomosis without protective stoma
Procedure: Primary anastomosis without protective stoma
Anastomosis with protective stoma
Procedure: Anastomosis with protective stoma
Primary anastomosis without protective stoma
Anastomosis with protective stoma
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.
Time frame: 12 months posteoperatively
Comparison of the rate of death between "with protective stoma" and "without protective stoma"
rate of death at 3 months after surgery (%)
Time frame: 3 months postoperatively
Comparison of the rate of reinterventions between "with protective stoma" and "without protective stoma"
the rate of reinterventions after the surgery (%)
Time frame: 12 months postoperatively
Comparison of the rate of incisional surgical site infection (SSI) between "with protective stoma" and "without protective stoma"
the rate of incisional SSI (%)
Time frame: 12 months postoperatively
Comparison of the rate of organ/space SSI between "with protective stoma" and "without protective stoma"
the rate of organ/space SSI (%)
Time frame: 12 months postoperatively
Comparison of the rate of wound disruptions between "with protective stoma" and "without protective stoma"
the rate of wound disruptions (%)
Time frame: 12 months postoperatively
Comparison of the rate of anastomotic leaks between "with protective stoma" and "without protective stoma"
the rate of anastomotic leaks (%)
Time frame: 12 months postoperatively
Comparison of operating time between "with protective stoma" and "without protective stoma"
time of surgery (hours)
Time frame: surgery
Comparison of length of postoperative hospital stay between "with protective stoma" and "without protective stoma"
Length of postoperative hospital stay (days)
Time frame: 6 months postoperatively
Comparison of Intensive Care Unit (ICU) length of stay between "with protective stoma" and "without protective stoma"
ICU length of stay (days)
Time frame: 6 months postoperatively
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
Time frame: 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
Time frame: 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
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
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
Time frame: 6, 12, 26 and 52 weeks after primary surgery
Comparison of the cost utility between "with protective stoma" and "without protective stoma"
Quality-Adjusted Life Year (QALY) derived from the EQ5D-5L questionnaire
Time frame: 12 months after primary surgery
Plan to share: No
Started Jun 2021 (actual). Primary completion is estimated for Sep 2026, 62 months after the start.
Of 23 interventional studies with no phase under Peritonitis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 62 months is above that.
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