Effect of Inguinal Hernia Repair on Isokinetic Muscle Strength

August 12, 2016 updated by: Barış Sevinç, Konya Meram State Hospital

The Evaluation of Trunk Muscle Strength, Quality of Life, and Neuropathic Pain Component After Two Different Inguinal Hernia Repair Techniques; A Prospective Controlled Trial

The aim of the present prospective controlled study is to compare the trunk muscle strength, quality of life and neuropathic pain component after Lichtenstein and Kugel procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study patients underwent inguinal hernia repair will be evaluated for the effect of the surgical procedure on abdominal muscle strength.

Study Type

Interventional

Enrollment (Actual)

100

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
      • Konya, Turkey, 42180
        • Konya Training and Research Hospital

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

Male

Description

Inclusion Criteria:

  • Signed written informed consent
  • Male gender (for minimizing the certain effect of gender to muscle strength)
  • Patients aged 18-65 years' old
  • Having no previous surgery
  • Patients within six months to postoperative first year
  • Ability to speak, read, and write Turkish

Exclusion Criteria:

  • Infections or tumors of the spine
  • Systemic bone or joint disorders (e.g., rheumatoid arthritis)
  • Unstable cardiovascular and pulmonary diseases
  • Polyneuropathies and musculoskeletal system diseases
  • Presence of a diagnosed severe psychiatric disorder
  • Presence of severe pain
  • Regular exercise habit
  • Recurrent operation for a hernia
  • Presence bilateral inguinal hernia on concurrent femoral hernia
  • If the calculated Body mass index is lower than 20kg/cm2 or over than 35kg/cm2

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: lichtenstein
lichtenstein procedure
Procedure: lichtenstein
tension free mesh hernioplasty (lichtenstein) procedure will be applied for inguinal hernia repair
Active Comparator: Kugel
Kugel procedure
Procedure: Kugel
preperitoneal mesh hernioplasty (Kugel) procedure will be applied for inguinal hernia repair
No Intervention: control
healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
isokinetic muscle strength
Time Frame: 6 - 12 months
Trunk muscle strength measurement using the Biodex System 3Pro Multi-joint System Isokinetic dynamometer. Peak torque (PT) and PT-based agonist/antagonist ratios will be used to reveal strength imbalances.
6 - 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life assesment
Time Frame: 6 -12 months
Quality of life assesment will be performed by Short Form 36 (SF-36) and The PainDETECT questionnaires (PD-Q).
6 -12 months

Collaborators and Investigators

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

Sponsor

Konya Meram State Hospital

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

December 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (Estimate)

August 18, 2016

Study Record Updates

Last Update Posted (Estimate)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 12, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • izokinetic01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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