A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial
herni
2 other identifiers
interventional
50
1 country
1
Brief Summary
This is a new inguinal hernia repair technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2001
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 27, 2009
CompletedFirst Posted
Study publicly available on registry
October 28, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedMay 4, 2011
October 1, 2009
5 years
October 27, 2009
May 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complications, recurrences
6 month
Study Arms (2)
study, control
NO INTERVENTIONControl: Only modified shouldice repair performed Study: Modified Shouldice + Moloney repairs performed
modified shouldice and double
NO INTERVENTIONone arm is only modified shouldice, other one is double
Interventions
one arm modified shouldice, other one is double repair
Eligibility Criteria
You may qualify if:
- Inguinal hernia
You may not qualify if:
- Recurrences, child
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
S.B. Istanbul Educational & Teaching Hospital
Istanbul, Marmara, 34565, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Arslan Kaygusuz, surgeon
S.B. Istanbul Educational & Teaching Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 27, 2009
First Posted
October 28, 2009
Study Start
January 1, 2001
Primary Completion
January 1, 2006
Study Completion
January 1, 2012
Last Updated
May 4, 2011
Record last verified: 2009-10