Effect of Inguinal Hernia Repair on Isokinetic Muscle Strength
The Evaluation of Trunk Muscle Strength, Quality of Life, and Neuropathic Pain Component After Two Different Inguinal Hernia Repair Techniques; A Prospective Controlled Trial
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 10, 2016
CompletedFirst Posted
Study publicly available on registry
August 18, 2016
CompletedAugust 18, 2016
August 1, 2016
2 months
August 10, 2016
August 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6 - 12 months
Secondary Outcomes (1)
quality of life assesment
6 -12 months
Study Arms (3)
lichtenstein
ACTIVE COMPARATORlichtenstein procedure
Kugel
ACTIVE COMPARATORKugel procedure
control
NO INTERVENTIONhealthy volunteers
Interventions
tension free mesh hernioplasty (lichtenstein) procedure will be applied for inguinal hernia repair
preperitoneal mesh hernioplasty (Kugel) procedure will be applied for inguinal hernia repair
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Konya Training and Research Hospital
Konya, 42180, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
August 10, 2016
First Posted
August 18, 2016
Study Start
December 1, 2013
Primary Completion
February 1, 2014
Study Completion
October 1, 2014
Last Updated
August 18, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share