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

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ClinicalTrials.gov Identifier: NCT01003509
Recruitment Status : Unknown
Verified October 2009 by SB Istanbul Education and Research Hospital.
Recruitment status was:  Recruiting
First Posted : October 28, 2009
Last Update Posted : May 4, 2011
Sponsor:
Information provided by:
SB Istanbul Education and Research Hospital

Brief Summary:
This is a new inguinal hernia repair technique.

Condition or disease Intervention/treatment Phase
Hernia Procedure: modified shouldice and double Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial
Study Start Date : January 2001
Actual Primary Completion Date : January 2006
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
No Intervention: study, control
Control: Only modified shouldice repair performed Study: Modified Shouldice + Moloney repairs performed
No Intervention: modified shouldice and double
one arm is only modified shouldice, other one is double
Procedure: modified shouldice and double
one arm modified shouldice, other one is double repair
Other Name: control group, study group




Primary Outcome Measures :
  1. complications, recurrences [ Time Frame: 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inguinal hernia

Exclusion Criteria:

  • Recurrences, child

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003509


Contacts
Contact: erhan mr aysan, assoc. prof. +902125884400 dr@webcerrah.com
Contact: hasan mr bektas, surgeon +902164356765 drhasanbektas@gmail.com

Locations
Turkey
S.B. Istanbul Educational & Teaching Hospital Recruiting
Istanbul, Marmara, Turkey, 34565
Contact: Arslan Kaygusuz, surgeon    +902125884400 ext 6684    akaygusuz@yahoo.com   
Contact: Ozgur yigit, surgeon    +905884400 ext 6141    ozguryigit@gmail.com   
Principal Investigator: erhan aysan, assoc. prof.         
Sponsors and Collaborators
SB Istanbul Education and Research Hospital
Investigators
Study Chair: Arslan Kaygusuz, surgeon S.B. Istanbul Educational & Teaching Hospital

Responsible Party: No any sponsor
ClinicalTrials.gov Identifier: NCT01003509     History of Changes
Other Study ID Numbers: hernia
aysan ( Other Identifier: Bezmialem vakif University )
First Posted: October 28, 2009    Key Record Dates
Last Update Posted: May 4, 2011
Last Verified: October 2009

Keywords provided by SB Istanbul Education and Research Hospital:
inguinal
hernia
new
repair
modified shouldice
double

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal