A New Approach in Inguinal Hernia Repair: Double Repair.... | NCT01003509

Studies
A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial

NCT01003509

Sponsor

SB Istanbul Education and Research Hospital

Status

Unknown status

Last Update Posted

May 4, 2011Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Hernia

Interventions

modified shouldice and double

Countries

Turkey (Türkiye)

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

ID	Type	Description	Link
aysan	Other Identifier	Bezmialem vakif University

Status Module

Record Verification Date

Oct 2009

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

Jan 2001

Primary Completion Date

Jan 2006Actual

Completion Date

Jan 2012Estimated

First Submitted Date

Oct 27, 2009

First Submission Date that Met QC Criteria

Oct 27, 2009

First Posted Date

Oct 28, 2009Estimated

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 3, 2011

Last Update Posted Date

May 4, 2011Estimated

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 new inguinal hernia repair technique.

Detailed Description

In this study we are revealing a new inguinal hernia repair technique. It is constructed from two layers. Deep layer is modified Shouldice technique, the other superficial one is moloney technique.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study, control	No Intervention	Control: Only modified shouldice repair performed Study: Modified Shouldice + Moloney repairs performed
modified shouldice and double	No Intervention	one arm is only modified shouldice, other one is double	Procedure: modified shouldice and double

Interventions

Name	Type	Description	Arm Group Labels	Other Names
modified shouldice and double	Procedure	one arm modified shouldice, other one is double repair	modified shouldice and double

Measure	Description	Time Frame
complications, recurrences		6 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inguinal hernia

Exclusion Criteria:

Recurrences, child

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
erhan mr aysan, assoc. prof.	Contact	+902125884400		dr@webcerrah.com
hasan mr bektas, surgeon	Contact	+902164356765		drhasanbektas@gmail.com

Overall Officials

Name	Affiliation	Role
Arslan Kaygusuz, surgeon	S.B. Istanbul Educational & Teaching Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
S.B. Istanbul Educational & Teaching Hospital	Recruiting	Istanbul	Marmara	34565	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D006547	Hernia

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided