Mesh Fixation With a Synthetic Glue in Primary Inguinal H... | NCT02507830

Studies
Mesh Fixation With a Synthetic Glue in Primary Inguinal Hernia Repair

NCT02507830

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Mar 3, 2016Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Inguinal Hernia

Interventions

Not provided

Countries

Israel

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

Mar 2016

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

Aug 2015

Primary Completion Date

Jul 2017Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Jul 20, 2015

First Submission Date that Met QC Criteria

Jul 23, 2015

First Posted Date

Jul 24, 2015Estimated

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

Mar 2, 2016

Last Update Posted Date

Mar 3, 2016Estimated

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

Prospective observational study with mesh fixation using FDA approved synthetic glue,glubran 2 and standard mesh fixation with stiches in primary inguinal hernia repair surgery. The investigators aim is to recruit 150 patients for the study.

The outcomes The investigators would like to determine are : postoperative pain,recurrences and complication rates such as seromas.

Detailed Description

The outcomes The investigators would like to determine are : postoperative pain,recurrences and complication rates such as seromas.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glubran 2 fixation		Mesh fixation with Glubran 2 glue in primary inguinal hernia repair

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative pain (Evaluation will be conducted through scale and a questionnaire )		2 years

Secondary Outcomes

Measure	Description	Time Frame
Hernia recurrence (Evaluation will be conducted through a questionnaire and physical examination )		2 years
Postoperative complications (Evaluation will be conducted through a questionnaire and physical examination )		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary Inguinal hernia

Exclusion Criteria:

Recurrent hernia
Large inguinoscrotal hernias
Bilateral inguinal hernias

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

adults older than 18 undergoing a primary inguinal hernia repair

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Adel Abu_Salih, MD	Contact	972-4-8541308		a_abu_salih@rambam.health.gov.il

Overall Officials

Name	Affiliation	Role
Adel Abu_Salih, MD	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Health Care Campus	Recruiting	Haifa			Israel

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