Back to resultsImpacts of Stoppa and Total Extraperitoneal Inguinal Hernia Repair on the Lower Extremity Muscular Functions
Primary Purpose
Hernia, Inguinal
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Stoppa inguinal hernia repair
Total extraperitoneal inguinal hernia repair
Sponsored by
About this trial
This is an interventional treatment trial for Hernia, Inguinal
Eligibility Criteria
Inclusion Criteria:
- Unilateral inguinal hernia
Exclusion Criteria:
- 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
Sites / Locations
- Akdeniz University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Stoppa repair
TEP repair
Arm Description
Stoppa inguinal hernia repair
Total extraperitoneal inguinal hernia repair
Outcomes
Primary Outcome Measures
Functional loss in lower extremity muscles
Physical activity parameters (isokinetic and isometric values) of the lower extremity muscular functions were measured with a dynamometer.
Secondary Outcome Measures
Duration of hospital stay
Postoperative pain score
Visual analog score assessment of post operative pain
Recurrence rate
Number of patients with recurrence
Complications
Complications like infection, seroma, hematoma, abscess, wound healing problems and urinary retension.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02813057
Brief Title
Impacts of Stoppa and Total Extraperitoneal Inguinal Hernia Repair on the Lower Extremity Muscular Functions
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akdeniz University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparison of physical activity parameters of the lower extremity muscles in patients who received total extraperitoneal repair (TEP) and STOPPA repair.
Detailed Description
The patients were evaluated during the preoperative period and in the postoperative day 3, to achieve an isometric and isokinetic, objective assessment of the pain-related lower extremity muscular function changes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stoppa repair
Arm Type
Active Comparator
Arm Description
Stoppa inguinal hernia repair
Arm Title
TEP repair
Arm Type
Experimental
Arm Description
Total extraperitoneal inguinal hernia repair
Intervention Type
Procedure
Intervention Name(s)
Stoppa inguinal hernia repair
Intervention Description
Stoppa inguinal hernia repair
Intervention Type
Procedure
Intervention Name(s)
Total extraperitoneal inguinal hernia repair
Intervention Description
Total extraperitoneal inguinal hernia repair
Primary Outcome Measure Information:
Title
Functional loss in lower extremity muscles
Description
Physical activity parameters (isokinetic and isometric values) of the lower extremity muscular functions were measured with a dynamometer.
Time Frame
postoperative day 3
Secondary Outcome Measure Information:
Title
Duration of hospital stay
Time Frame
From time of admission to time of discharge an approximate length of three days
Title
Postoperative pain score
Description
Visual analog score assessment of post operative pain
Time Frame
Postoperative 12 hour
Title
Recurrence rate
Description
Number of patients with recurrence
Time Frame
Postoperative 4 months
Title
Complications
Description
Complications like infection, seroma, hematoma, abscess, wound healing problems and urinary retension.
Time Frame
Postoperative 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral inguinal hernia
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayhan Mesci, Assoc. Prof.
Organizational Affiliation
Akdeniz University
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz University
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27942876
Citation
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.
Results Reference
derived
Learn more about this trial
Impacts of Stoppa and Total Extraperitoneal Inguinal Hernia Repair on the Lower Extremity Muscular Functions
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