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

Federico II University

Status: Unknown

Conditions: Incisional Hernia

Study type: Observational

Funder types: Other

Identifiers

NCT05400083

471/20

Details and patient eligibility

About

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 .

Enrollment: 203 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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