Status:
UNKNOWN
Prevention of Incisional Hernia With Biosynthetic Mesh at the Site of Temporary Ileostomy Closure (PRINCESS)
Lead Sponsor:
Federico II University
Conditions:
Incisional Hernia
Eligibility:
All Genders
18+ years
Brief Summary
Prophylactic mesh reinforcement of the abdominal wall at the site of temporary ileostomy closure is effective in preventing postoperative incisional hernia. This prospective, multicenter, observation...
Eligibility Criteria
Inclusion
- Subjects will be informed about the study, and will have read; understood and signed the informed consent
- 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
- Subjects who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study
- Subjects with parastomal hernia or midline incisional hernia
- Subjects who required midline laparotomy during ileostomy reversal
Key Trial Info
Start Date :
May 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT05400083
Start Date
May 17 2021
End Date
May 1 2024
Last Update
June 3 2022
Active Locations (1)
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1
Minimally Invasive General and Oncologic Surgery Unit - Univesity of Naples Federico II
Naples, Italy, 80131