Inguinal HerniaNCT02871583
Effect of Inguinal Hernia Repair on Isokinetic Muscle Strength
A study testing lichtenstein and Kugel in people with Inguinal Hernia, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- lichtenstein and Kugel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Training and Research Hospital
Konya, 42180
About this study
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
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.
Read the detailed description
In this study patients underwent inguinal hernia repair will be evaluated for the effect of the surgical procedure on abdominal muscle strength.
- Conditions
- Inguinal Hernia
- Being tested
- lichtenstein, Kugel
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lichtensteinProcedure or surgery
tension free mesh hernioplasty (lichtenstein) procedure will be applied for inguinal hernia repair
KugelProcedure or surgery
preperitoneal mesh hernioplasty (Kugel) procedure will be applied for inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| lichtenstein | Active comparator | lichtenstein procedure Receives: Procedure: lichtenstein |
| Kugel | Active comparator | Kugel procedure Receives: Procedure: Kugel |
| control | No intervention | healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 - 12 months
Secondary outcomes (1)
quality of life assesment
Quality of life assesment will be performed by Short Form 36 (SF-36) and The PainDETECT questionnaires (PD-Q).
Measured: 6 -12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startDec 2013
- Primary completionFeb 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barış Sevinç, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871583
- Sponsor's protocol ID
- izokinetic01
- Status last verified
- Aug 2016
- First submitted
- 10 Aug 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02871583
- Acronym / sponsor ID
- izokinetic01
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lichtenstein | Active comparator | Procedure: lichtensteinlichtenstein procedure |
| Kugel | Active comparator | Procedure: KugelKugel procedure |
| control | No intervention | –healthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lichtensteintension free mesh hernioplasty (lichtenstein) procedure will be applied for inguinal hernia repair | Procedure or surgery | lichtenstein |
| Kugelpreperitoneal mesh hernioplasty (Kugel) procedure will be applied for inguinal hernia repair | Procedure or surgery | Kugel |
Primary outcome
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.
1 secondary outcome
quality of life assesment
Time frame: 6 -12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lichtenstein and Kugel in people with Inguinal Hernia, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
isokinetic muscle strength (time frame: 6 - 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2016.