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3D printed button may ease ostomy anxiety before surgery

NCT ID NCT04326335

Symptom relief Sponsor: Centre Hospitalier Departemental Vendee Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether placing a 3D printed button on the abdomen before surgery helps ostomy patients adjust better. Fifty adults scheduled for a temporary ostomy were split into two groups: one got standard felt-tip marking, the other got the 3D button plus marking. Researchers measured quality of life after surgery using a special questionnaire. The goal was to see if the 3D button reduces anxiety and improves outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
3D printed ostomy button
What this could lead to
If it works, this could give future ostomy patients a better idea of what to expect, potentially reducing anxiety and improving quality of life after surgery.
What could go wrong
This is a small pilot study with only 50 participants, so results may not apply to everyone. The benefit over simple felt-tip marking may be small or nonexistent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50 people

The number who actually took part.

Started

Jul 2020

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

OSTOMY

Contacts and locations

Locations

  • Centre Hospitalier Departemental Vendee

    La Roche-sur-Yon, France

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