Comparison of Mesh Fixation Wit Cyanoacrylate vs Suture i... | NCT02197585

Studies
Comparison of Mesh Fixation Wit Cyanoacrylate vs Suture in Inguinal Hernia Surgery

NCT02197585

Sponsor

Hospital del Mar

Status

Completed

Last Update Posted

Jul 22, 2014Estimated

Enrollment

150Actual

Phase

Not Applicable

Conditions

Chronic Pain

Interventions

Inguinal mesh hernioplasty

Countries

Not provided

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

Jul 2014

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

Jun 2007

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jul 21, 2014

First Submission Date that Met QC Criteria

Jul 21, 2014

First Posted Date

Jul 22, 2014Estimated

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

Jul 21, 2014

Last Update Posted Date

Jul 22, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To compare fixation with glubran2 with suture during surgery por primary inguinal hernia.

Hypothesis: Glue may induce less complications and chronic pain than suture

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

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glue	Experimental	Mesh fixation with glue	Procedure: Inguinal mesh hernioplasty
Suture	Active Comparator	Mesh fixation with suture	Procedure: Inguinal mesh hernioplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inguinal mesh hernioplasty	Procedure		Glue Suture

Measure	Description	Time Frame
Chronic pain after two years		24 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male patients
Aged more than 18 years
Primary inguinal hernia

Exclusion Criteria:

Inguinoscrotal hernia

Accepts Healthy Volunteers

Sex

Male

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

Name	Affiliation	Role
JA Pereira, MD	Hospital del Mar	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided