Effect of Inguinal Hernia Repair on Isokinetic Muscle Strength

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871583
• Other study ID #: izokinetic01
• Status: Completed
• Phase: N/A
• First received: August 10, 2016
• Last updated: August 12, 2016
• Start date: December 2013
• Est. completion date: October 2014

Study information

• Verified date: August 2016
• Source: Konya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• lichtenstein
tension free mesh hernioplasty (lichtenstein) procedure will be applied for inguinal hernia repair
• Kugel
preperitoneal mesh hernioplasty (Kugel) procedure will be applied for inguinal hernia repair

Locations

Country	Name	City	State
Turkey	Konya Training and Research Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	quality of life assesment	Quality of life assesment will be performed by Short Form 36 (SF-36) and The PainDETECT questionnaires (PD-Q).	6 -12 months	No