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

• Conditions: Incisional Hernia

• Registration Number: NCT05400083
• Lead Sponsor: Federico II University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-17
• Status Verified: 2022-05
• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-26
• Last Update Submitted: 2022-05-31
• Study First Posted: 2022-06-01
• Last Update Posted: 2022-06-03
• Primary Completion: 2023-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incisional hernia rate	at 24 months	CT scan or Ultrasound as imaging to detect incisional hernia

Secondary Outcome Measures

Name	Time	Method
Early and Long-term Complication Rates	after surgery to 24 months	Clavien-Dindo classification
Postoperative pain	after surgery to 24 months	Visual analogue scales (VAS) Range: 1-100. Higher score correlates with more pain
Quality of life by Carolinas Comfort Scale (CCS) and Euro-Qol 5D-5L questionnaires	after surgery to 24 months	CCS - Range: 0-115. Higher score correlates with worse outcome
Budget Impact Analysis	after surgery to 24 months	Healthcare Cost Analysis including direct costs (fixed and variable)

Trial Locations

Locations (1)

Minimally Invasive General and Oncologic Surgery Unit - Univesity of Naples Federico II; 🇮🇹 Naples, Italy