Impacts of Stoppa and Total Extraperitoneal Inguinal Hernia Repair on the Lower Extremity Muscular Functions
Quantitative Assessment of the Impacts of Stoppa Repair and Total Extraperitoneal Repair on the Lower Extremity Muscular Functions in Cases of Unilateral Inguinal Hernia; a Randomized Controlled Study
1 other identifier
interventional
50
1 country
1
Brief Summary
Comparison of physical activity parameters of the lower extremity muscles in patients who received total extraperitoneal repair (TEP) and STOPPA repair.
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 Mar 2012
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
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 20, 2016
CompletedFirst Posted
Study publicly available on registry
June 24, 2016
CompletedJune 24, 2016
June 1, 2016
11 months
June 20, 2016
June 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Functional loss in lower extremity muscles
Physical activity parameters (isokinetic and isometric values) of the lower extremity muscular functions were measured with a dynamometer.
postoperative day 3
Secondary Outcomes (4)
Duration of hospital stay
From time of admission to time of discharge an approximate length of three days
Postoperative pain score
Postoperative 12 hour
Recurrence rate
Postoperative 4 months
Complications
Postoperative 1 month
Study Arms (2)
Stoppa repair
ACTIVE COMPARATORStoppa inguinal hernia repair
TEP repair
EXPERIMENTALTotal extraperitoneal inguinal hernia repair
Interventions
Total extraperitoneal inguinal hernia repair
Eligibility Criteria
You may qualify if:
- Unilateral inguinal hernia
You may not qualify if:
- Contralateral hernia repair history
- Recurrent inguinal hernia
- Incarceration or strangulation
- Bilateral inguinal hernia
- Severe congestive heart failure
- Severe hypertension
- Rheumatoid arthritis
- Systemic or neurologic diseases altering lower extremity functions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Akdeniz University
Antalya, 07059, Turkey (Türkiye)
Related Publications (1)
Akgul N, Yaprak M, Dogru V, Balci N, Arici C, Mesci A. Quantitative assessment of the impacts of stoppa repair and total extraperitoneal repair on the lower extremity muscular functions in cases of unilateral inguinal hernia: a randomized controlled study. Hernia. 2017 Jun;21(3):377-382. doi: 10.1007/s10029-016-1559-6. Epub 2016 Dec 10.
PMID: 27942876DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ayhan Mesci, Assoc. Prof.
Akdeniz University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2016
First Posted
June 24, 2016
Study Start
March 1, 2012
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
June 24, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share