Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients

Ostomy Clinical Trial

— Stomie 3D  

Official title:

Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04326335
• Other study ID #: CHD197-19
• Status: Recruiting
• Phase: N/A
• Start date: July 29, 2020
• Est. completion date: September 2023

Study information

• Verified date: January 2022
• Source: Centre Hospitalier Departemental Vendee
• Contact: Laura SOULARD
• Phone: 02 51 08 05 82
• Email: laura.soulard[@]ght85.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ostomy

Intervention

Other:
• Felt-tip marking
Marking the location of the future stoma with a felt pen
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier Departemental Vendee	La Roche sur Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	2 months post-discharge