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Effect of Inguinal Hernia Repair on Isokinetic Muscle Strength

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
lichtenstein
Kugel
Sponsored by
Konya Meram State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Konya Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

lichtenstein

Kugel

control

Arm Description

lichtenstein procedure

Kugel procedure

healthy volunteers

Outcomes

Primary Outcome Measures

isokinetic muscle strength
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.

Secondary Outcome Measures

quality of life assesment
Quality of life assesment will be performed by Short Form 36 (SF-36) and The PainDETECT questionnaires (PD-Q).

Full Information

First Posted
August 10, 2016
Last Updated
August 12, 2016
Sponsor
Konya Meram State Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02871583
Brief Title
Effect of Inguinal Hernia Repair on Isokinetic Muscle Strength
Official Title
The Evaluation of Trunk Muscle Strength, Quality of Life, and Neuropathic Pain Component After Two Different Inguinal Hernia Repair Techniques; A Prospective Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Meram State Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lichtenstein
Arm Type
Active Comparator
Arm Description
lichtenstein procedure
Arm Title
Kugel
Arm Type
Active Comparator
Arm Description
Kugel procedure
Arm Title
control
Arm Type
No Intervention
Arm Description
healthy volunteers
Intervention Type
Procedure
Intervention Name(s)
lichtenstein
Intervention Description
tension free mesh hernioplasty (lichtenstein) procedure will be applied for inguinal hernia repair
Intervention Type
Procedure
Intervention Name(s)
Kugel
Intervention Description
preperitoneal mesh hernioplasty (Kugel) procedure will be applied for inguinal hernia repair
Primary Outcome Measure Information:
Title
isokinetic muscle strength
Description
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.
Time Frame
6 - 12 months
Secondary Outcome Measure Information:
Title
quality of life assesment
Description
Quality of life assesment will be performed by Short Form 36 (SF-36) and The PainDETECT questionnaires (PD-Q).
Time Frame
6 -12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Konya Training and Research Hospital
City
Konya
ZIP/Postal Code
42180
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Effect of Inguinal Hernia Repair on Isokinetic Muscle Strength

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