CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled / 50 target
Drug / intervention
Felt-tip marking +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04326335
NCT04326335N/ACompletedOn Track (0.7/mo)Completion was 22mo ago

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

Centre Hospitalier Departemental Vendee·interventional·Posted Mar 30, 2020·Updated Jun 12, 2026

In Brief

A clinical study evaluating Felt-tip marking and Felt-tip marking + 3D printed ostomy button for Ostomy. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOstomy
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 30, 2020
Enrollment StartJul 29, 2020
Primary CompletionAug 12, 2024
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 6.3 years ago

Arms & Interventions

Felt-tip markingactive_comparator

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

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

Interventions

Felt-tip markingother

Marking the location of the future stoma with a felt pen

Felt-tip marking + 3D printed ostomy buttonother

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