Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients (Stomie 3D)
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|ClinicalTrials.gov Identifier: NCT04326335|
Recruitment Status : Not yet recruiting
First Posted : March 30, 2020
Last Update Posted : April 1, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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|
|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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326335
|Contact: Chloé MOREAUfirstname.lastname@example.org|
|Centre Hospitalier Departemental Vendee|
|La Roche sur Yon, France|
|Principal Investigator: Emeric ABET|
|Principal Investigator:||Emeric ABET||Centre Hospitalier Departemental Vendee|