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

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.

Study Overview

• Status: Recruiting
• Conditions: Ostomy
• Intervention / Treatment: Other: Felt-tip marking; Other: Felt-tip marking + 3D printed ostomy button

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura SOULARD; Phone Number: 02 51 08 05 82; Email: laura.soulard@ght85.fr

Study Locations

• France
  • La Roche sur Yon, France
    • Recruiting
    • Centre Hospitalier Departemental Vendée
    • Principal Investigator: Emeric ABET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Felt-tip marking	Other: Felt-tip marking; Marking the location of the future stoma with a felt pen
Experimental: Felt-tip marking + 3D printed ostomy button	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Emeric ABET, Centre Hospitalier Departemental Vendée

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2020
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CHD197-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No