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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05400083

Acronym

PRINCESS

Enrollment

203

Registered

2022-06-01

Start date

2021-05-17

Completion date

2024-05-31

Last updated

2022-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernia

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 .

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Incisional hernia rate	at 24 months	CT scan or Ultrasound as imaging to detect incisional hernia

Secondary

Measure	Time frame	Description
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)

Countries

Italy

Contacts

Primary ContactUmberto Bracale, Prof

umbertobracale@gmail.com+390817462544

Outcome results