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

Primary Purpose

Hernia

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
modified shouldice and double
Sponsored by
SB Istanbul Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia focused on measuring inguinal, hernia, new, repair, modified shouldice, double

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Inguinal hernia

Exclusion Criteria:

  • Recurrences, child

Sites / Locations

  • S.B. Istanbul Educational & Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

No Intervention

Arm Label

study, control

modified shouldice and double

Arm Description

Control: Only modified shouldice repair performed Study: Modified Shouldice + Moloney repairs performed

one arm is only modified shouldice, other one is double

Outcomes

Primary Outcome Measures

complications, recurrences

Secondary Outcome Measures

Full Information

First Posted
October 27, 2009
Last Updated
May 3, 2011
Sponsor
SB Istanbul Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01003509
Brief Title
A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial
Acronym
herni
Official Title
A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2001 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
SB Istanbul Education and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia
Keywords
inguinal, hernia, new, repair, modified shouldice, double

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study, control
Arm Type
No Intervention
Arm Description
Control: Only modified shouldice repair performed Study: Modified Shouldice + Moloney repairs performed
Arm Title
modified shouldice and double
Arm Type
No Intervention
Arm Description
one arm is only modified shouldice, other one is double
Intervention Type
Procedure
Intervention Name(s)
modified shouldice and double
Other Intervention Name(s)
control group, study group
Intervention Description
one arm modified shouldice, other one is double repair
Primary Outcome Measure Information:
Title
complications, recurrences
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inguinal hernia Exclusion Criteria: Recurrences, child
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
erhan mr aysan, assoc. prof.
Phone
+902125884400
Email
dr@webcerrah.com
First Name & Middle Initial & Last Name or Official Title & Degree
hasan mr bektas, surgeon
Phone
+902164356765
Email
drhasanbektas@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arslan Kaygusuz, surgeon
Organizational Affiliation
S.B. Istanbul Educational & Teaching Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
S.B. Istanbul Educational & Teaching Hospital
City
Istanbul
State/Province
Marmara
ZIP/Postal Code
34565
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arslan Kaygusuz, surgeon
Phone
+902125884400
Ext
6684
Email
akaygusuz@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ozgur yigit, surgeon
Phone
+905884400
Ext
6141
Email
ozguryigit@gmail.com
First Name & Middle Initial & Last Name & Degree
erhan aysan, assoc. prof.

12. IPD Sharing Statement

Learn more about this trial

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

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