Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients
Stomie 3D
1 other identifier
interventional
50
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2020
CompletedFirst Posted
Study publicly available on registry
March 30, 2020
CompletedStudy Start
First participant enrolled
July 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedOctober 14, 2022
January 1, 2022
3.1 years
March 26, 2020
October 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Felt-tip marking
ACTIVE COMPARATORFelt-tip marking + 3D printed ostomy button
EXPERIMENTALInterventions
Marking the location of the future stoma with a felt pen + 3D printed ostomy button placed on the future stoma location
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Departemental Vendee
La Roche-sur-Yon, France
Study Officials
- PRINCIPAL INVESTIGATOR
Emeric ABET
Centre Hospitalier Departemental Vendee
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2020
First Posted
March 30, 2020
Study Start
July 29, 2020
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
October 14, 2022
Record last verified: 2022-01