Minimally Invasive Open Preperitoneal Surgery With Polyso... | NCT00323674

Studies
Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery With Light Weight Mesh

NCT00323674

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Sep 5, 2023Actual

Enrollment

278Actual

Phase

Not Applicable

Conditions

Hernia, Inguinal

Interventions

Polysoft Mesh
Light Weight Mesh

Countries

Belgium

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

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006Actual

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 31, 2015Actual

First Submitted Date

May 7, 2006

First Submission Date that Met QC Criteria

May 7, 2006

First Posted Date

May 9, 2006Estimated

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

Aug 31, 2023

Last Update Posted Date

Sep 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This is a prospective randomized study to evaluate the recovery of a hernia inguinalis by a minimally invasive open preperitoneal surgery with polysoft mesh versus a classic open surgery according to modified Lichtenstein procedure with light weight mesh.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

278Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Light Weight Mesh	Active Comparator		Device: Light Weight Mesh
Polysoft Mesh	Active Comparator		Device: Polysoft Mesh

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polysoft Mesh	Device	Polysoft Mesh is used.	Polysoft Mesh
Light Weight Mesh

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of relapse		Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
Postoperative pain assessment		Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
Duration to full recovery (able to do all activities)		Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic hernia inguinalis
> 18 years

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederik Berrevoet, MD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

Label	URL
Website of the University Hospital Ghent	View source

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided