Prevention of Incisional Hernia With Biosynthetic Mesh at the Site of Temporary Ileostomy Closure (PRINCESS)
NCT ID: NCT05400083
Last Updated: 2022-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
203 participants
OBSERVATIONAL
2021-05-17
2024-05-31
Brief Summary
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This prospective, multicenter, observational study will evaluate performance of Phasix biosynthetic mesh when used to reinforce fascial closure .
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Subjects of either gender that are at least the age of 18 years
* Subjects will be undergoing ileostomy reversal with retromuscular placement technique of the Phasix biosynthetic mesh reinforcement
Exclusion Criteria
* Subjects with parastomal hernia or midline incisional hernia
* Subjects who required midline laparotomy during ileostomy reversal
18 Years
ALL
No
Sponsors
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Federico II University
OTHER
Responsible Party
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Umberto Bracale
Prof.
Locations
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Minimally Invasive General and Oncologic Surgery Unit - Univesity of Naples Federico II
Naples, , Italy
Countries
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Central Contacts
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Facility Contacts
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Umberto Bracale, Prof
Role: primary
Other Identifiers
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471/20
Identifier Type: -
Identifier Source: org_study_id
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