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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Felt-tip marking | Active Comparator |
| |
| Felt-tip marking + 3D printed ostomy button | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Felt-tip marking | Other | Marking the location of the future stoma with a felt pen |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months post-discharge, up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emeric ABET | Centre Hospitalier Departemental Vendee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Departemental Vendee | La Roche-sur-Yon | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Felt-tip Marking | Felt-tip marking: Marking the location of the future stoma with a felt pen |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Felt-tip Marking | Felt-tip marking: Marking the location of the future stoma with a felt pen |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 2 months post-discharge, up to 3 months |
|
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Death, serious adverse events and other (non serious adverse events) were not assessed for the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Felt-tip Marking | Felt-tip marking: Marking the location of the future stoma with a felt pen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Emeric ABET | CHD Vendée | 02 51 44 61 48 | +33 | emeric.abet@ght85.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2023 | Jun 11, 2026 | Prot_SAP_000.pdf |
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| Felt-tip marking + 3D printed ostomy button |
| Other |
Marking the location of the future stoma with a felt pen + 3D printed ostomy button placed on the future stoma location |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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