Prevention of Incisional Hernia With Biosynthetic Mesh at... | NCT05400083

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

NCT05400083

Sponsor

Federico II University

Status

Unknown status

Last Update Posted

Jun 3, 2022Actual

Enrollment

203Estimated

Phase

Not provided

Conditions

Incisional Hernia

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 17, 2021Actual

Primary Completion Date

May 2023Estimated

Completion Date

May 2024Estimated

First Submitted Date

May 24, 2022

First Submission Date that Met QC Criteria

May 26, 2022

First Posted Date

Jun 1, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2022

Last Update Posted Date

Jun 3, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

203Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Early and Long-term Complication Rates	Clavien-Dindo classification	after surgery to 24 months
Postoperative pain	Visual analogue scales (VAS) Range: 1-100. Higher score correlates with more pain

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

General and teaching hospitals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Umberto Bracale, Prof	Contact	+390817462544		umbertobracale@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Minimally Invasive General and Oncologic Surgery Unit - Univesity of Naples Federico II	Recruiting	Naples		80131	Italy

Condition Browse Module

MeSH Terms

ID	Term
D000069290	Incisional Hernia

Ancestor Terms

ID	Term
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided