Trial Outcomes & Findings for Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients (NCT NCT04326335)
NCT ID: NCT04326335
Last Updated: 2026-06-12
Results Overview
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.
COMPLETED
NA
50 participants
2 months post-discharge, up to 3 months
2026-06-12
Participant Flow
Participant milestones
| Measure |
Felt-tip Marking
Felt-tip marking: Marking the location of the future stoma with a felt pen
|
Felt-tip Marking + 3D Printed Ostomy Button
Felt-tip marking + 3D printed ostomy button: Marking the location of the future stoma with a felt pen + 3D printed ostomy button placed on the future stoma location
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Felt-tip Marking
n=23 Participants
Felt-tip marking: Marking the location of the future stoma with a felt pen
|
Felt-tip Marking + 3D Printed Ostomy Button
n=25 Participants
Felt-tip marking + 3D printed ostomy button: Marking the location of the future stoma with a felt pen + 3D printed ostomy button placed on the future stoma location
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 15 • n=23 Participants
|
65 years
STANDARD_DEVIATION 9 • n=25 Participants
|
65 years
STANDARD_DEVIATION 12 • n=48 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=23 Participants
|
6 Participants
n=25 Participants
|
16 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=23 Participants
|
19 Participants
n=25 Participants
|
32 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
23 participants
n=23 Participants
|
25 participants
n=25 Participants
|
48 participants
n=48 Participants
|
PRIMARY outcome
Timeframe: 2 months post-discharge, up to 3 monthsTotal 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.
Outcome measures
| Measure |
Felt-tip Marking
n=23 Participants
Felt-tip marking: Marking the location of the future stoma with a felt pen
|
Felt-tip Marking + 3D Printed Ostomy Button
n=25 Participants
Felt-tip marking + 3D printed ostomy button: Marking the location of the future stoma with a felt pen + 3D printed ostomy button placed on the future stoma location
|
|---|---|---|
|
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.
|
60.1 score on a scale
Interval 55.7 to 64.6
|
60.6 score on a scale
Interval 56.4 to 64.8
|
Adverse Events
Felt-tip Marking
Felt-tip Marking + 3D Printed Ostomy Button
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place