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Impacts of Stoppa and Total Extraperitoneal Inguinal Hernia Repair on the Lower Extremity Muscular Functions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813057
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Akdeniz University

Brief Summary:
Comparison of physical activity parameters of the lower extremity muscles in patients who received total extraperitoneal repair (TEP) and STOPPA repair.

Condition or disease Intervention/treatment Phase
Hernia, Inguinal Procedure: Stoppa inguinal hernia repair Procedure: Total extraperitoneal inguinal hernia repair Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: Stoppa repair
Stoppa inguinal hernia repair
Procedure: Stoppa inguinal hernia repair
Stoppa inguinal hernia repair

Experimental: TEP repair
Total extraperitoneal inguinal hernia repair
Procedure: Total extraperitoneal inguinal hernia repair
Total extraperitoneal inguinal hernia repair




Primary Outcome Measures :
  1. Functional loss in lower extremity muscles [ Time Frame: postoperative day 3 ]
    Physical activity parameters (isokinetic and isometric values) of the lower extremity muscular functions were measured with a dynamometer.


Secondary Outcome Measures :
  1. Duration of hospital stay [ Time Frame: From time of admission to time of discharge an approximate length of three days ]
  2. Postoperative pain score [ Time Frame: Postoperative 12 hour ]
    Visual analog score assessment of post operative pain

  3. Recurrence rate [ Time Frame: Postoperative 4 months ]
    Number of patients with recurrence

  4. Complications [ Time Frame: Postoperative 1 month ]
    Complications like infection, seroma, hematoma, abscess, wound healing problems and urinary retension.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02813057


Locations
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Turkey
Akdeniz University
Antalya, Turkey, 07059
Sponsors and Collaborators
Akdeniz University
Investigators
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Study Director: Ayhan Mesci, Assoc. Prof. Akdeniz University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Akdeniz University
ClinicalTrials.gov Identifier: NCT02813057    
Other Study ID Numbers: 201203
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal