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

Centre Hospitalier Departemental Vendee

Status

Unknown

Conditions

Ostomy

Treatments

Other: Felt-tip marking + 3D printed ostomy button

Other: Felt-tip marking

Study type

Interventional

Funder types

Other

Identifiers

NCT04326335

CHD197-19

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.