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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by SB Istanbul Education and Research Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
SB Istanbul Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT01003509
First received: October 27, 2009
Last updated: May 3, 2011
Last verified: October 2009
  Purpose

This is a new inguinal hernia repair technique.


Condition Intervention
Hernia
Procedure: modified shouldice and double

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by SB Istanbul Education and Research Hospital:

Primary Outcome Measures:
  • complications, recurrences [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2001
Estimated Study Completion Date: January 2012
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inguinal hernia

Exclusion Criteria:

  • Recurrences, child
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: No any sponsor
ClinicalTrials.gov Identifier: NCT01003509     History of Changes
Other Study ID Numbers: hernia, aysan
Study First Received: October 27, 2009
Last Updated: May 3, 2011
Health Authority: Turkey: Ministry of Health

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

ClinicalTrials.gov processed this record on August 19, 2014