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

NCT04326335 | Completed Results

• 1 other identifier: CHD197-19
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ostomy

Outcome Measures

Primary Outcomes (1)

• 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, up to 3 months

Study Arms (2)

Felt-tip marking

ACTIVE COMPARATOR

Other: Felt-tip marking

Felt-tip marking + 3D printed ostomy button

EXPERIMENTAL

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

Interventions

Felt-tip marking OTHER

Marking the location of the future stoma with a felt pen

Felt-tip marking

Felt-tip marking + 3D printed ostomy button OTHER

Marking the location of the future stoma with a felt pen + 3D printed ostomy button placed on the future stoma location

Felt-tip marking + 3D printed ostomy button

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (1)

Centre Hospitalier Departemental Vendee

La Roche-sur-Yon, France

Location

Results Point of Contact

• Title: Dr Emeric ABET
• Organization: CHD Vendée

emeric.abet@ght85.fr

02 51 44 61 48

Study Officials

• Emeric ABET

  Centre Hospitalier Departemental Vendee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: July 29, 2020
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: June 12, 2026
• Results First Posted: June 12, 2026

Record last verified: 2026-06

Locations

FR (1)