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

June 22, 2016 updated by: Akdeniz University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07059
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
postoperative day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of hospital stay
Time Frame: From time of admission to time of discharge an approximate length of three days
From time of admission to time of discharge an approximate length of three days
Postoperative pain score
Time Frame: Postoperative 12 hour
Visual analog score assessment of post operative pain
Postoperative 12 hour
Recurrence rate
Time Frame: Postoperative 4 months
Number of patients with recurrence
Postoperative 4 months
Complications
Time Frame: Postoperative 1 month
Complications like infection, seroma, hematoma, abscess, wound healing problems and urinary retension.
Postoperative 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Investigators

  • Study Director: Ayhan Mesci, Assoc. Prof., Akdeniz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (ESTIMATE)

June 24, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2016

Last Update Submitted That Met QC Criteria

June 22, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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