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Completed

NCT Number: NCT02813057

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University

Antalya, 07059, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stoppa inguinal hernia repair

Procedure

Stoppa inguinal hernia repair

Total extraperitoneal inguinal hernia repair

Procedure

Total extraperitoneal inguinal hernia repair

Primary outcomes

  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 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

    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.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 24, 2016
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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