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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04326335
Recruitment Status : Not yet recruiting
First Posted : March 30, 2020
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

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.


Condition or disease Intervention/treatment Phase
Ostomy Other: Felt marking Other: 3D printed ostomy button Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy

Arm Intervention/treatment
Active Comparator: Felt marking Other: Felt marking
Marking the location of the future stoma with a felt

Experimental: 3D printed ostomy button Other: 3D printed ostomy button
3D printed ostomy button placed on the future stoma location




Primary Outcome Measures :
  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. [ Time Frame: 2 months post-discharge ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326335


Contacts
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Contact: Chloé MOREAU 0251446327 chloe.moreau@chd-vendee.fr

Locations
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France
Centre Hospitalier Departemental Vendee
La Roche sur Yon, France
Principal Investigator: Emeric ABET         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
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Principal Investigator: Emeric ABET Centre Hospitalier Departemental Vendee

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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT04326335    
Other Study ID Numbers: CHD197-19
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No