Prevention of Incisional Hernia With Biosynthetic Mesh at the Site of Temporary Ileostomy Closure (PRINCESS) (PRINCESS)

  • STATUS
    Recruiting
  • End date
    May 19, 2024
  • participants needed
    203
  • sponsor
    Federico II University
Updated on 19 June 2022
incisional hernia

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, observational study will evaluate performance of Phasix biosynthetic mesh when used to reinforce fascial closure .

Details
Condition Incisional Hernia
Clinical Study IdentifierNCT05400083
SponsorFederico II University
Last Modified on19 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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