Hernia, InguinalNCT02813057
Impacts of Stoppa and Total Extraperitoneal Inguinal Hernia Repair on the Lower Extremity Muscular Functions
A study testing Stoppa inguinal hernia repair and Total extraperitoneal inguinal hernia repair in people with Hernia, Inguinal, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Comparison of physical activity parameters of the lower extremity muscles in patients who received total extraperitoneal repair (TEP) and STOPPA repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Stoppa inguinal hernia repair and Total extraperitoneal inguinal hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2012to Feb 2013
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral inguinal hernia
Who cannot join
- Contralateral hernia repair history
- Recurrent inguinal hernia
- Incarceration or strangulation
- Bilateral inguinal hernia
- Severe congestive heart failure
- Severe hypertension
- Rheumatoid arthritis
- Systemic or neurologic diseases altering lower extremity functions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Assessment of the Impacts of Stoppa Repair and Total Extraperitoneal Repair on the Lower Extremity Muscular Functions in Cases of Unilateral Inguinal Hernia; a Randomized Controlled Study
Comparison of physical activity parameters of the lower extremity muscles in patients who received total extraperitoneal repair (TEP) and STOPPA repair.
Read the detailed description
The patients were evaluated during the preoperative period and in the postoperative day 3, to achieve an isometric and isokinetic, objective assessment of the pain-related lower extremity muscular function changes.
- Conditions
- Hernia, Inguinal
- Being tested
- Stoppa inguinal hernia repair, Total extraperitoneal inguinal hernia repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stoppa inguinal hernia repairProcedure or surgery
Stoppa inguinal hernia repair
Total extraperitoneal inguinal hernia repairProcedure or surgery
Total extraperitoneal inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Stoppa repair | Active comparator | Stoppa inguinal hernia repair Receives: Procedure: Stoppa inguinal hernia repair |
| TEP repair | Experimental | Total extraperitoneal inguinal hernia repair Receives: Procedure: Total extraperitoneal inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional loss in lower extremity muscles
Physical activity parameters (isokinetic and isometric values) of the lower extremity muscular functions were measured with a dynamometer.
Measured: postoperative day 3
Secondary outcomes (4)
Duration of hospital stay
Measured: From time of admission to time of discharge an approximate length of three days
Postoperative pain score
Visual analog score assessment of post operative pain
Measured: Postoperative 12 hour
Recurrence rate
Number of patients with recurrence
Measured: Postoperative 4 months
Complications
Complications like infection, seroma, hematoma, abscess, wound healing problems and urinary retension.
Measured: Postoperative 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startMar 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayhan Mesci, Assoc. Prof., Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813057
- Sponsor's protocol ID
- 201203
- Status last verified
- Jun 2016
- First submitted
- 20 Jun 2016
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Akgul N, Yaprak M, Dogru V, Balci N, Arici C, Mesci A. Quantitative assessment of the impacts of stoppa repair and total extraperitoneal repair on the lower extremity muscular functions in cases of unilateral inguinal hernia: a randomized controlled study. Hernia. 2017 Jun;21(3):377-382. doi: 10.1007/s10029-016-1559-6. Epub 2016 Dec 10.
PubMed 27942876
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of the Impacts of Stoppa Repair and Total Extraperitoneal Repair on the Lower Extremity Muscular Functions in Cases of Unilateral Inguinal Hernia; a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02813057
- Acronym / sponsor ID
- 201203
- Conditions
- Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Jun 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.
Comparison of physical activity parameters of the lower extremity muscles in patients who received total extraperitoneal repair (TEP) and STOPPA repair.
Detailed description
The patients were evaluated during the preoperative period and in the postoperative day 3, to achieve an isometric and isokinetic, objective assessment of the pain-related lower extremity muscular function changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stoppa repair | Active comparator | Procedure: Stoppa inguinal hernia repairStoppa inguinal hernia repair |
| TEP repair | Experimental | Procedure: Total extraperitoneal inguinal hernia repairTotal extraperitoneal inguinal hernia repair |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral inguinal hernia
Key exclusion criteria (8 listed)
- Contralateral hernia repair history
- Recurrent inguinal hernia
- Incarceration or strangulation
- Bilateral inguinal hernia
- Severe congestive heart failure
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 |
|---|---|---|
| Stoppa inguinal hernia repairStoppa inguinal hernia repair | Procedure or surgery | Stoppa repair |
| Total extraperitoneal inguinal hernia repairTotal extraperitoneal inguinal hernia repair | Procedure or surgery | TEP repair |
Primary outcome
Functional loss in lower extremity muscles
Time frame: postoperative day 3
Physical activity parameters (isokinetic and isometric values) of the lower extremity muscular functions were measured with a dynamometer.
4 secondary outcomes
Duration of hospital stay
Time frame: From time of admission to time of discharge an approximate length of three days
Postoperative pain score
Time frame: Postoperative 12 hour
Recurrence rate
Time frame: Postoperative 4 months
Complications
Time frame: Postoperative 1 month
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 24 Jun 2016.
- Derived from this study: PubMed 27942876Akgul N, Yaprak M, Dogru V, Balci N, Arici C, Mesci A. Quantitative assessment of the impacts of stoppa repair and total extraperitoneal repair on the lower extremity muscular functions in cases of unilateral inguinal hernia: a randomized controlled study. Hernia. 2017 Jun;21(3):377-382. doi: 10.1007/s10029-016-1559-6. Epub 2016 Dec 10.
- Individual participant dataSharing planned: No
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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.
Ayhan Mesci, Assoc. Prof. study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stoppa inguinal hernia repair and Total extraperitoneal inguinal hernia repair in people with Hernia, Inguinal, run by Akdeniz University 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 1 inclusion and 8 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 24 Jun 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?
Functional loss in lower extremity muscles (time frame: postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02813057, which also lists 1 linked publication.
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 24 Jun 2016.