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

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


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 .

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


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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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