OstomyStomie 3DNCT04326335
Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients
A study testing Felt-tip marking and Felt-tip marking + 3D printed ostomy button in people with Ostomy, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
The making of an ostomy in patients is experienced as traumatic. The stoma changes body image, self-esteem and is responsible for increased anxiety. These changes affect the quality of life of patients. To reduce the negative impact of the stoma, patients are seen in preoperative consultation by the stoma nurses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy
- What is being tested?
- Felt-tip marking and Felt-tip marking + 3D printed ostomy button
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jul 2020to 12 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient ≥ 18 years old,
- First ileostomy with indication for temporary stoma placement,
- Patient with scheduled surgery,
- Patient who has the capacity to understand the protocol and has given consent to participate in the research,
- Patient with social security coverage.
Who cannot join
- Patient < 18 years old,
- Patient with an indication for placement of a permanent stoma,
- Emergency surgery patient,
- Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception,
- Patient under guardianship, curators or legal protection,
- Patient participating in another interventional clinical research protocol involving a drug or medical device.
Trial locations and contacts
1 site in 1 country.
About this study
The making of an ostomy in patients is experienced as traumatic. The stoma changes body image, self-esteem and is responsible for increased anxiety. These changes affect the quality of life of patients. To reduce the negative impact of the stoma, patients are seen in preoperative consultation by the stoma nurses. This consultation allows to show the patients the appearance of a stoma (through a photograph), the equipment used and how it works.
In 2016, McKenna et al. showed the interest of marking (with felt pen) the ostomy site on the abdomen in preoperative. In this study, patients with preoperative marking had a higher post-operative quality of life score than patients without marking (p=0.03).
Read more
Quality of life was assessed using the STOMA-QOL score. This quality of life score is specific for ostomy patients. It assesses 4 dimensions: sleep, intimate relationships, relationships with family and close friends, relationships with people other than family and close friends. This questionnaire includes 20 questions and has been validated in 5 languages including French.
The aim of this pilot study is to evaluate the post-operative quality of life of ostomy patients who have benefited from a preoperative therapeutic education session with the placement of the 3D printed ostomy button versus felt-tip marking, during the 15 days prior to the operation.
- Conditions
- Ostomy
- Being tested
- Felt-tip marking, Felt-tip marking + 3D printed ostomy button
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Felt-tip markingOther
Marking the location of the future stoma with a felt pen
Felt-tip marking + 3D printed ostomy buttonOther
Marking the location of the future stoma with a felt pen + 3D printed ostomy button placed on the future stoma location
| Study group | Role | What they receive |
|---|---|---|
| Felt-tip marking | Active comparator | Not described Receives: Other: Felt-tip marking |
| Felt-tip marking + 3D printed ostomy button | Experimental | Not described Receives: Other: Felt-tip marking + 3D printed ostomy button |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Post-operative Quality of Life of Ostomy Patients Having Benefited From Preoperative Therapeutic Education Sessions With 3D Printed Ostomy Button Placement Versus Felt Marking.
Total score on the Stoma-QOL (Quality-Of-Life) questionnaire The points obtained for each of the 20 questions are added together to obtain an overall score. This raw summary score per patient in the 20-80 range will be converted into a final score "0-100 score" where 0 indicates the worst Quality of Life and 100 the best Quality of Life.
Measured: 2 months post-discharge, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start29 Jul 2020
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OstomyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emeric ABET, Principal investigator, Centre Hospitalier Departemental Vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326335
- Sponsor's protocol ID
- CHD197-19
- Acronym
- Stomie 3D
- Status last verified
- Jun 2026
- First submitted
- 26 Mar 2020
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients
- ClinicalTrials.gov ID
- NCT04326335
- Acronym / sponsor ID
- Stomie 3D / CHD197-19
- Conditions
- Ostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Posted 12 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The making of an ostomy in patients is experienced as traumatic. The stoma changes body image, self-esteem and is responsible for increased anxiety. These changes affect the quality of life of patients. To reduce the negative impact of the stoma, patients are seen in preoperative consultation by the stoma nurses. This consultation allows to show the patients the appearance of a stoma (through a photograph), the equipment used and how it works.
In 2016, McKenna et al. showed the interest of marking (with felt pen) the ostomy site on the abdomen in preoperative. In this study, patients with preoperative marking had a higher post-operative quality of life score than patients without marking (p=0.03).
Quality of life was assessed using the STOMA-QOL score. This quality of life score is specific for ostomy patients. It assesses 4 dimensions: sleep, intimate relationships, relationships with family and close friends, relationships with people other than family and close friends. This questionnaire includes 20 questions and has been validated in 5 languages including French.
The aim of this pilot study is to evaluate the post-operative quality of life of ostomy patients who have benefited from a preoperative therapeutic education session with the placement of the 3D printed ostomy button versus felt-tip marking, during the 15 days prior to the operation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Felt-tip marking | Active comparator | Other: Felt-tip marking |
| Felt-tip marking + 3D printed ostomy button | Experimental | Other: Felt-tip marking + 3D printed ostomy button |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient ≥ 18 years old,
- First ileostomy with indication for temporary stoma placement,
- Patient with scheduled surgery,
- Patient who has the capacity to understand the protocol and has given consent to participate in the research,
- Patient with social security coverage.
Key exclusion criteria (6 listed)
- Patient < 18 years old,
- Patient with an indication for placement of a permanent stoma,
- Emergency surgery patient,
- Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception,
- Patient under guardianship, curators or legal protection,
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 |
|---|---|---|
| Felt-tip markingMarking the location of the future stoma with a felt pen | Other | Felt-tip marking |
| Felt-tip marking + 3D printed ostomy buttonMarking the location of the future stoma with a felt pen + 3D printed ostomy button placed on the future stoma location | Other | Felt-tip marking + 3D printed ostomy button |
Primary outcome
Evaluate the Post-operative Quality of Life of Ostomy Patients Having Benefited From Preoperative Therapeutic Education Sessions With 3D Printed Ostomy Button Placement Versus Felt Marking.
Time frame: 2 months post-discharge, up to 3 months
Total score on the Stoma-QOL (Quality-Of-Life) questionnaire The points obtained for each of the 20 questions are added together to obtain an overall score. This raw summary score per patient in the 20-80 range will be converted into a final score "0-100 score" where 0 indicates the worst Quality of Life and 100 the best Quality of Life.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Ostomy
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Conducting Wound, Ostomy, and Continence (WOC) Nurse Telephone Follow-up for Post-discharge Ostomy Patients to Reduce Hospital Readmission
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Suture Choice for Ostomy Creation
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The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
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Novel Post-Surgical Incision Management to Prevent Ostomy Complications
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Artificial Intelligence-Supported Nursing Program for Sleep Quality in People With an Ostomy
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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. This study is not recruiting at the moment.
Emeric ABET principal investigator
Centre Hospitalier Departemental Vendee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Felt-tip marking and Felt-tip marking + 3D printed ostomy button in people with Ostomy, run by Centre Hospitalier Departemental Vendee 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 12 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 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?
Yes. Results are posted in the registry (first posted 12 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the Post-operative Quality of Life of Ostomy Patients Having Benefited From Preoperative Therapeutic Education Sessions With 3D Printed Ostomy Button Placement Versus Felt Marking. (time frame: 2 months post-discharge, up to 3 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 12 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.