Colorectal AnastomosisRESTODIGNCT06881303
Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion
A study testing preoperative stoma identification and education in people with Colorectal Anastomosis and Endometrial, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
There are many indications for performing a fecal diversion stoma. In both scheduled and emergency situations, and whatever the context (indication or type of fecal diversion stoma), stomal complications can occur early (10-60%) or late (25%), and may require repeat surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Anastomosis, Endometrial, Anastomotic Leak Rectum
- What is being tested?
- preoperative stoma identification and education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2026to 1 Mar 2028
- 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
- Men or women aged 18 and over
- for whom a fecal diversion stoma is planned on a scheduled or emergency basis
- affiliated with the French social security system
Who cannot join
- Patient in a period of exclusion from another research protocol at the time of signing the no-objection form,
- Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women),
- No digestive stoma or fecal diversion planned
- Person who does not understand French
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Assistance publique - Hôpitaux de Marseille
Marseille
Maéva Donadieu-Masse, 0491435817 ext. 33, promotion.interne@ap-hm.fr
About this study
There are many indications for performing a fecal diversion stoma. In both scheduled and emergency situations, and whatever the context (indication or type of fecal diversion stoma), stomal complications can occur early (10-60%) or late (25%), and may require repeat surgery. The most frequent complications are necrosis, retraction, bleeding, evisceration, occlusion, abscess, hyperflow with hydroelectrolytic consequences, skin lesions, prolapse or eventration. What's more, a temporary stoma can become permanent.
The positioning and fabrication of the digestive stoma for fecal diversion must therefore comply with well-defined criteria to reduce the risk of stomal complications and the difficulties of fitting the stoma, and thus improve the autonomy and therefore the quality of life of the ostomate patient. The guide to good stoma therapy practice recommends that the site of the future stoma should be marked out preoperatively. What's more, the psychological impact of a stoma is such that preoperative and regular postoperative education is essential. This identification and initiation of education is carried out by stoma nurses and/or surgeons.
Read more
The impact of preoperative stoma identification and education on stoma complications, quality of life and patient autonomy has been reported in a few comparative series. The impact of preoperative education on quality of life has also been reported.
However, despite this "Evidence Based Medicine", and the guide to good stoma therapy practice, the identification and education of the future fecal diversion stoma are not always carried out preoperatively. Reasons for this may include lack of time, lack of human resources, in the general context of a shrinking public hospital, or in the current context of distancing and dehumanization of the profession, or lack of conviction on the part of practitioners.
To this end, the investigators would like to propose a prospective observational study aimed at evaluating the impact of identification and education prior to the performance of a fecal diversion stoma in a programmed situation on the one hand, and an emergency situation on the other.
The main objective will be to compare quality of life specifically related to the stoma at 30 days postoperatively with the StomaQOL score, between 2 groups of patients:
- unexposed group: no preoperative stoma identification and education
- exposed group: preoperative stoma identification and education. This comparison will be stratified according to whether surgery is scheduled or emergency surgery.
Total 100 patients :
- In scheduled surgery: 30 exposed and 30 unexposed patients
- In emergency surgery: 10 exposed and 30 unexposed patients
Timeline:
Inclusion period: 12 months Follow-up period: 12 months Total duration: 24 months
- Conditions
- Colorectal Anastomosis, Endometrial, Anastomotic Leak Rectum, Ulcerative Colitis (Disorder), Adenomatous Polyposis Coli, Familial, Crohn Disease
- Being tested
- preoperative stoma identification and education
- Medical subject headings
- Colitis, Ulcerative, Adenomatous Polyposis Coli, Crohn Disease, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative stoma identification and educationOther
The guide to good stoma therapy practice recommends that the site of the future stoma should be marked out preoperatively, in the lying, sitting and standing positions, so that the patient can see the stoma. What's more, the psychological impact of the stoma is such that preoperative and regular postoperative education is essential. This identification and initiation of education is carried out by stoma nurses and/or surgeons.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative identification and education | Experimental | Not described Receives: Other: preoperative stoma identification and education |
| lack of preoperative identification and education | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnary : quality of life
Measured: From enrollment to the end of the study at 24 months
Secondary outcomes (8)
occurrence of short-term stomatal complications (within 30 days days post-operatively)
edema, necrosis, retraction, bleeding, evisceration, occlusion, abscess, hyperflow with hydroelectrolytic consequences, skin lesions
Measured: From intervention to 30 days after intervention
Questionnaire about the patient's autonomy when returning home (stoma therapist needed or not; if present, for how long)
stoma therapist needed or not; if present, for how long
Measured: From intervention to 30 days after intervention
rate of long-term stomatal complications at 1 year
prolapse, occlusion, ventration
Measured: From intervention to1 year after intervention
questionnaire on ostomy-specific quality of life, assessed by the StomaQOL score at 30 days, for comparison between identification and education by the stoma nurse or surgeon
Measured: From intervention to 30 days after intervention
Questionnaire on ostomy-specific quality of life, assessed by the StomaQOL score at 1 years
Measured: From intervention to 1 year after intervention
SF36 quality of life questionnaire at 30 days and 1 year
Measured: From intervention to 1 year after intervention
Rate of restoration of digestive continuity at 1 year
Measured: From intervention to 1 year after intervention
Reasons for not carrying out preoperative identification and education
emergency, surgery at night or on weekends or public holidays, insufficient preoperative time, stoma nurse absent, surgeon's choice, patient's wishes.
Measured: From enrollment to the end of the study at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AnastomosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881303
- Sponsor's protocol ID
- RCAPHM23_0029
- Other IDs
- 2023-A01631-44
- Acronym
- RESTODIG
- Status last verified
- Nov 2025
- First submitted
- 5 Mar 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion
- ClinicalTrials.gov ID
- NCT06881303
- Acronym / sponsor ID
- RESTODIG / RCAPHM23_0029
- Conditions
- Colorectal Anastomosis, Endometrial, Anastomotic Leak Rectum, Ulcerative Colitis (Disorder), Adenomatous Polyposis Coli, Familial, Crohn Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 18 Mar 2025 (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.
There are many indications for performing a fecal diversion stoma. In both scheduled and emergency situations, and whatever the context (indication or type of fecal diversion stoma), stomal complications can occur early (10-60%) or late (25%), and may require repeat surgery. The most frequent complications are necrosis, retraction, bleeding, evisceration, occlusion, abscess, hyperflow with hydroelectrolytic consequences, skin lesions, prolapse or eventration. What's more, a temporary stoma can become permanent.
The positioning and fabrication of the digestive stoma for fecal diversion must therefore comply with well-defined criteria to reduce the risk of stomal complications and the difficulties of fitting the stoma, and thus improve the autonomy and therefore the quality of life of the ostomate patient. The guide to good stoma therapy practice recommends that the site of the future stoma should be marked out preoperatively. What's more, the psychological impact of a stoma is such that preoperative and regular postoperative education is essential. This identification and initiation of education is carried out by stoma nurses and/or surgeons.
The impact of preoperative stoma identification and education on stoma complications, quality of life and patient autonomy has been reported in a few comparative series. The impact of preoperative education on quality of life has also been reported.
However, despite this "Evidence Based Medicine", and the guide to good stoma therapy practice, the identification and education of the future fecal diversion stoma are not always carried out preoperatively. Reasons for this may include lack of time, lack of human resources, in the general context of a shrinking public hospital, or in the current context of distancing and dehumanization of the profession, or lack of conviction on the part of practitioners.
To this end, the investigators would like to propose a prospective observational study aimed at evaluating the impact of identification and education prior to the performance of a fecal diversion stoma in a programmed situation on the one hand, and an emergency situation on the other.
The main objective will be to compare quality of life specifically related to the stoma at 30 days postoperatively with the StomaQOL score, between 2 groups of patients:
- unexposed group: no preoperative stoma identification and education
- exposed group: preoperative stoma identification and education. This comparison will be stratified according to whether surgery is scheduled or emergency surgery.
Total 100 patients :
- In scheduled surgery: 30 exposed and 30 unexposed patients
- In emergency surgery: 10 exposed and 30 unexposed patients
Timeline:
Inclusion period: 12 months Follow-up period: 12 months Total duration: 24 months
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative identification and education | Experimental | Other: preoperative stoma identification and education |
| lack of preoperative identification and education | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women aged 18 and over
- for whom a fecal diversion stoma is planned on a scheduled or emergency basis
- affiliated with the French social security system
Key exclusion criteria (4 listed)
- Patient in a period of exclusion from another research protocol at the time of signing the no-objection form,
- Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women),
- No digestive stoma or fecal diversion planned
- Person who does not understand French
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 |
|---|---|---|
| preoperative stoma identification and educationThe guide to good stoma therapy practice recommends that the site of the future stoma should be marked out preoperatively, in the lying, sitting and standing positions, so that the patient can see the stoma. What's more, the psychological impact of the stoma is such that preoperative and regular postoperative education is essential. This identification and initiation of education is carried out by stoma nurses and/or surgeons. | Other | Preoperative identification and education |
Primary outcome
Questionnary : quality of life
Time frame: From enrollment to the end of the study at 24 months
8 secondary outcomes
occurrence of short-term stomatal complications (within 30 days days post-operatively)
Time frame: From intervention to 30 days after intervention
Questionnaire about the patient's autonomy when returning home (stoma therapist needed or not; if present, for how long)
Time frame: From intervention to 30 days after intervention
rate of long-term stomatal complications at 1 year
Time frame: From intervention to1 year after intervention
questionnaire on ostomy-specific quality of life, assessed by the StomaQOL score at 30 days, for comparison between identification and education by the stoma nurse or surgeon
Time frame: From intervention to 30 days after intervention
Questionnaire on ostomy-specific quality of life, assessed by the StomaQOL score at 1 years
Time frame: From intervention to 1 year after intervention
SF36 quality of life questionnaire at 30 days and 1 year
Time frame: From intervention to 1 year after intervention
Rate of restoration of digestive continuity at 1 year
Time frame: From intervention to 1 year after intervention
Reasons for not carrying out preoperative identification and education
Time frame: From enrollment to the end of the study at 24 months
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 18 Nov 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative stoma identification and education in people with Colorectal Anastomosis and Endometrial, run by Assistance Publique Hopitaux De Marseille at 1 site 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Maéva Donadieu-Masse (0491435817 ext. 33, promotion.interne@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnary : quality of life (time frame: From enrollment to the end of the study at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.