Clinical trial NCT04326335: Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients
Official title: Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ostomy
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
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.
timeFrame: 2 months post-discharge
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Departemental Vendee
Study officials:
affiliation: Centre Hospitalier Departemental Vendee
name: Emeric ABET
role: PRINCIPAL_INVESTIGATOR
References: