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

Incisional Hernia Clinical Trial

— PRINCESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05400083
• Other study ID #: 471/20
• Status: Recruiting
• Start date: May 17, 2021
• Est. completion date: May 2024

Study information

• Verified date: May 2022
• Source: Federico II University
• Contact: Umberto Bracale, Prof
• Phone: +390817462544
• Email: umbertobracale[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 203
• Est. completion date: May 2024
• Est. primary completion date: May 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Locations

Country	Name	City	State
Italy	Minimally Invasive General and Oncologic Surgery Unit - Univesity of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incisional hernia rate	CT scan or Ultrasound as imaging to detect incisional hernia	at 24 months
Secondary	Early and Long-term Complication Rates	Clavien-Dindo classification	after surgery to 24 months
Secondary	Postoperative pain	Visual analogue scales (VAS) Range: 1-100. Higher score correlates with more pain	after surgery to 24 months
Secondary	Quality of life by Carolinas Comfort Scale (CCS) and Euro-Qol 5D-5L questionnaires	CCS - Range: 0-115. Higher score correlates with worse outcome	after surgery to 24 months
Secondary	Budget Impact Analysis	Healthcare Cost Analysis including direct costs (fixed and variable)	after surgery to 24 months