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CompletedNCT02813057Updated Jun 24, 2016

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

An interventional study of Stoppa inguinal hernia repair and Total extraperitoneal inguinal hernia repair in Hernia, Inguinal, sponsored by Akdeniz University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-06-24.

Sponsored by Akdeniz University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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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Conditions studied

  • Hernia, Inguinal
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In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 50 is below the median of 80 across 739 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Akdeniz University is the lead sponsor of 289 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Unilateral inguinal hernia

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Stoppa repair

    Stoppa inguinal hernia repair

    Procedure: Stoppa inguinal hernia repair

  • Experimental
    TEP repair

    Total extraperitoneal inguinal hernia repair

    Procedure: Total extraperitoneal inguinal hernia repair

Interventions

  • ProcedureStoppa inguinal hernia repair

    Stoppa inguinal hernia repair

  • ProcedureTotal extraperitoneal inguinal hernia repair

    Total extraperitoneal inguinal hernia repair

06

What researchers measure

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.

    Time frame: postoperative day 3

Secondary outcomes

  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

    Visual analog score assessment of post operative pain

    Time frame: Postoperative 12 hour

  3. Recurrence rate

    Number of patients with recurrence

    Time frame: Postoperative 4 months

  4. Complications

    Complications like infection, seroma, hematoma, abscess, wound healing problems and urinary retension.

    Time frame: Postoperative 1 month

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Study locations

1 site
  • Akdeniz University
    Antalya, 07059, Turkey
08

References and documents

Publications

  • 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. PubMed 27942876 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02813057
Lead sponsor
Akdeniz University
Responsible party
Sponsor
First posted
Jun 24, 2016
Start date
Mar 2012
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Jun 24, 2016

Study contacts

Ayhan Mesci, Assoc. Prof.
study director · Akdeniz University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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