Effect of Inguinal Hernia Repair on Isokinetic Muscle Str... | NCT02871583

Studies
Effect of Inguinal Hernia Repair on Isokinetic Muscle Strength

NCT02871583

Sponsor

Konya Meram State Hospital

Status

Completed

Last Update Posted

Aug 18, 2016Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Inguinal Hernia

Interventions

lichtenstein
Kugel

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Aug 10, 2016

First Submission Date that Met QC Criteria

Aug 12, 2016

First Posted Date

Aug 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2016

Last Update Posted Date

Aug 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lichtenstein	Active Comparator	lichtenstein procedure	Procedure: lichtenstein
Kugel	Active Comparator	Kugel procedure	Procedure: Kugel
control	No Intervention	healthy volunteers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lichtenstein	Procedure	tension free mesh hernioplasty (lichtenstein) procedure will be applied for inguinal hernia repair	lichtenstein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Konya Training and Research Hospital		Konya		42180	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided