PeritonitisDIVERTI2NCT04604730
Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis
A study testing Primary anastomosis without protective stoma and Anastomosis with protective stoma in people with Peritonitis, run by University Hospital, Rouen at 20 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritonitis
- What is being tested?
- Primary anastomosis without protective stoma and Anastomosis with protective stoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 20 sitesFrance
- Study dates
- 11 Jun 2021to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- 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
- 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.
- Patient able to comply with the study protocol, in the investigator's judgment
- Patient affiliated with, or beneficiary of a social security (health insurance) category
- Non-inclusion Criteria:
Show all 16Show fewer
- Physical states that prevent patient participation (e.g. septic shock or multivisceral failure)
- Steroid treatment > 20 mg daily
- Prior pelvic irradiation
- Immunocompromised status
- Known progressive cancer
- American Society of Anesthesiologists grade IV
- Peritonitis secondary to perforated diverticulitis of the right colon
- Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study
- Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
- Simultaneous participation in another interventional research
Who cannot join
- 1. Failure to obtain the consent of the patient or the patient's representative
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 20 recruiting
- Recruiting
CHU Amiens
Amiens
Jean-Marc REGIMBEAU
Jean-Marc REGIMBEAU
- Not yet recruiting
CHR Beauvais
Beauvais, Beauvais, 60021
Francois MAUVAIS, MD, +33 344 11 ext. 2626, f.mauvais@ch-beauvais.fr
- Not yet recruiting
CH Beauvais
Beauvais
François MAUVAIS
François MAUVAIS
- Not yet recruiting
CHU Besançon
Besançon
Zaher LAKKIS
Zaher LAKKIS
- Not yet recruiting
APHP Avicenne
Bobigny
Christophe TRESALLET
Christophe TRESALLET
- Recruiting
CHU Brest
Brest
Bogdan BADIC
Bogdan BADIC
- Not yet recruiting
CHU Caen
Caen
Arnaud ALVES
Arnaud ALVES
- Not yet recruiting
CHU Clermont Ferrand
Clermont-Ferrand
Anne DUBOIS
Anne DUBOIS
- Not yet recruiting
APHP Henri Mondor
Créteil
Nicolas DE'ANGELIS
Nicolas DE'ANGELIS
- Not yet recruiting
CHU Grenoble
Grenoble
Jean-Luc FAUCHERON
Jean-Luc FAUCHERON
- Not yet recruiting
CHU Limoges
Limoges
Muriel MATHONNET
Muriel MATHONNET
- Not yet recruiting
CHU Lyon
Lyon
Eddy COTTE
Eddy COTTE
- Recruiting
APHM Hôpital Nord
Marseille
Laura BEYER BERJOT
Laura BEYER BERJOT
- Recruiting
APHM La Timone
Marseille
Diane MEGE
Diane MEGE
- Not yet recruiting
CHU Nancy
Nancy
Adeline GERMAIN
Adeline GERMAIN
- Not yet recruiting
CHU Nantes
Nantes
Guillaume MEURETTE
Guillaume MEURETTE
- Not yet recruiting
CHU Nimes
Nîmes
Michel PRUDHOMME
Michel PRUDHOMME
- Not yet recruiting
APHP St Antoine
Paris
Yann PARC
Yann PARC
- Recruiting
CHU Rouen
Rouen
Valérie BRIDOUX
Valérie BRIDOUX
- Recruiting
CHU Tours
Tours
Mehdi OUAISSI
Mehdi OUAISSI
About this study
Official title: Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis: a Prospective Multicenter Randomized Trial
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
Read the 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
- Conditions
- Peritonitis
- Being tested
- Primary anastomosis without protective stoma, Anastomosis with protective stoma
- Keywords
- peritonitis, perforated diverticulitis, primary anastomosis, protective stoma
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary anastomosis without protective stomaProcedure or surgery
Primary anastomosis without protective stoma
Anastomosis with protective stomaProcedure or surgery
Anastomosis with protective stoma
| Study group | Role | What they receive |
|---|---|---|
| Primary anastomosis without protective stoma | Experimental | Primary anastomosis without protective stoma Receives: Procedure: Primary anastomosis without protective stoma |
| Anastomosis with protective stoma | Active comparator | Anastomosis with protective stoma Receives: Procedure: Anastomosis with protective stoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months posteoperatively
Secondary outcomes (14)
Comparison of the rate of death between "with protective stoma" and "without protective stoma"
rate of death at 3 months after surgery (%)
Measured: 3 months postoperatively
Comparison of the rate of reinterventions between "with protective stoma" and "without protective stoma"
the rate of reinterventions after the surgery (%)
Measured: 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 (%)
Measured: 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 (%)
Measured: 12 months postoperatively
Comparison of the rate of wound disruptions between "with protective stoma" and "without protective stoma"
the rate of wound disruptions (%)
Measured: 12 months postoperatively
Comparison of the rate of anastomotic leaks between "with protective stoma" and "without protective stoma"
the rate of anastomotic leaks (%)
Measured: 12 months postoperatively
Comparison of operating time between "with protective stoma" and "without protective stoma"
time of surgery (hours)
Measured: surgery
Comparison of length of postoperative hospital stay between "with protective stoma" and "without protective stoma"
Length of postoperative hospital stay (days)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months after primary surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start11 Jun 2021
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sequential assignment
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie BRIDOUX, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604730
- Sponsor's protocol ID
- 2019/0409/HP
- Other IDs
- 2020-A01538-31
- Acronym
- DIVERTI2
- Status last verified
- Sep 2025
- First submitted
- 15 Oct 2020
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pinson J, Tuech JJ, Ouaissi M, Mathonnet M, Mauvais F, Houivet E, Lacroix E, Rondeaux J, Sabbagh C, Bridoux V. Role of protective stoma after primary anastomosis for generalized peritonitis due to perforated diverticulitis-DIVERTI 2 (a prospective multicenter randomized trial): rationale and design (nct04604730). BMC Surg. 2022 May 16;22(1):191. doi: 10.1186/s12893-022-01589-w.
PubMed 35578267
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis: a Prospective Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT04604730
- Acronym / sponsor ID
- DIVERTI2 / 2019/0409/HP
- Conditions
- Peritonitis
- Keywords
- peritonitis, perforated diverticulitis, primary anastomosis, protective stoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential assignment
| Arm | Type | Receives |
|---|---|---|
| Primary anastomosis without protective stoma | Experimental | Procedure: Primary anastomosis without protective stomaPrimary anastomosis without protective stoma |
| Anastomosis with protective stoma | Active comparator | Procedure: Anastomosis with protective stomaAnastomosis with protective stoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years
- 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
- 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.
- Patient able to comply with the study protocol, in the investigator's judgment
- Patient affiliated with, or beneficiary of a social security (health insurance) category
Key exclusion criteria (1 listed)
- 1. Failure to obtain the consent of the patient or the patient's representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary anastomosis without protective stomaPrimary anastomosis without protective stoma | Procedure or surgery | Primary anastomosis without protective stoma |
| Anastomosis with protective stomaAnastomosis with protective stoma | Procedure or surgery | Anastomosis with protective stoma |
Primary outcome
Comparison of overall morbidity between "with protective stoma" and "without protective stoma"
Time frame: 12 months posteoperatively
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.
14 secondary outcomes
Comparison of the rate of death between "with protective stoma" and "without protective stoma"
Time frame: 3 months postoperatively
Comparison of the rate of reinterventions between "with protective stoma" and "without protective stoma"
Time frame: 12 months postoperatively
Comparison of the rate of incisional surgical site infection (SSI) between "with protective stoma" and "without protective stoma"
Time frame: 12 months postoperatively
Comparison of the rate of organ/space SSI between "with protective stoma" and "without protective stoma"
Time frame: 12 months postoperatively
Comparison of the rate of wound disruptions between "with protective stoma" and "without protective stoma"
Time frame: 12 months postoperatively
Comparison of the rate of anastomotic leaks between "with protective stoma" and "without protective stoma"
Time frame: 12 months postoperatively
Comparison of operating time between "with protective stoma" and "without protective stoma"
Time frame: surgery
Comparison of length of postoperative hospital stay between "with protective stoma" and "without protective stoma"
Time frame: 6 months postoperatively
Comparison of Intensive Care Unit (ICU) length of stay between "with protective stoma" and "without protective stoma"
Time frame: 6 months postoperatively
Comparison of the number of patients alive without stoma between "with protective stoma" and "without protective stoma"
Time frame: 12 months after initial surgery
Comparison of the quality of life between "with protective stoma" and "without protective stoma"
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
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
Time frame: 6, 12, 26 and 52 weeks after primary surgery
Comparison of the cost utility between "with protective stoma" and "without protective stoma"
Time frame: 12 months after primary surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 35578267Pinson J, Tuech JJ, Ouaissi M, Mathonnet M, Mauvais F, Houivet E, Lacroix E, Rondeaux J, Sabbagh C, Bridoux V. Role of protective stoma after primary anastomosis for generalized peritonitis due to perforated diverticulitis-DIVERTI 2 (a prospective multicenter randomized trial): rationale and design (nct04604730). BMC Surg. 2022 May 16;22(1):191. doi: 10.1186/s12893-022-01589-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valérie BRIDOUX, Pr principal investigator
University Hospital, Rouen
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary anastomosis without protective stoma and Anastomosis with protective stoma in people with Peritonitis, run by University Hospital, Rouen at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie BRIDOUX, Pr (02 32 88 81 42, valerie.bridoux@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of overall morbidity between "with protective stoma" and "without protective stoma" (time frame: 12 months posteoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04604730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.