Status:
UNKNOWN
Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients
Lead Sponsor:
Centre Hospitalier Departemental Vendee
Conditions:
Ostomy
Eligibility:
All Genders
18+ years
Phase:
NA
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 patient...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04326335
Start Date
July 29 2020
End Date
September 1 2023
Last Update
October 14 2022
Active Locations (1)
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1
Centre Hospitalier Departemental Vendee
La Roche-sur-Yon, France