HerniaherniNCT01003509
A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial
A study testing modified shouldice and double in people with Hernia, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This is a new inguinal hernia repair technique. Read more about this study
- Who is it for?
- Ages 16 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hernia
- What is being tested?
- modified shouldice and double
- 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
- Jan 2001to Jan 2012
- 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 16 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Inguinal hernia
Who cannot join
- Recurrences, child
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
S.B. Istanbul Educational & Teaching Hospital
Istanbul, Marmara, 34565
Arslan Kaygusuz, surgeon, +902125884400 ext. 6684, akaygusuz@yahoo.com
Ozgur yigit, surgeon, +905884400 ext. 6141, ozguryigit@gmail.com
About this study
This is a new inguinal hernia repair technique.
Read the detailed description
In this study we are revealing a new inguinal hernia repair technique. It is constructed from two layers. Deep layer is modified Shouldice technique, the other superficial one is moloney technique.
- Conditions
- Hernia
- Being tested
- modified shouldice and double
- Keywords
- inguinal, hernia, new, repair, modified shouldice, double
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified shouldice and doubleProcedure or surgery
Also called control group, study group
one arm modified shouldice, other one is double repair
| Study group | Role | What they receive |
|---|---|---|
| study, control | No intervention | Control: Only modified shouldice repair performed Study: Modified Shouldice + Moloney repairs performed |
| modified shouldice and double | No intervention | one arm is only modified shouldice, other one is double Receives: Procedure: modified shouldice and double |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications, recurrences
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startJan 2001
- Primary completionJan 2006
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SB Istanbul Education and Research Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Arslan Kaygusuz, surgeon, Study chair, S.B. Istanbul Educational & Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003509
- Sponsor's protocol ID
- hernia
- Other IDs
- aysan
- Acronym
- herni
- Status last verified
- Oct 2009
- First submitted
- 27 Oct 2009
- Last updated
- 4 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01003509
- Acronym / sponsor ID
- herni / hernia
- Conditions
- Hernia
- Keywords
- inguinal, hernia, new, repair, modified shouldice, double
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SB Istanbul Education and Research HospitalUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2012 (estimated)
- First posted
- 28 Oct 2009 (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.
This is a new inguinal hernia repair technique.
Detailed description
In this study we are revealing a new inguinal hernia repair technique. It is constructed from two layers. Deep layer is modified Shouldice technique, the other superficial one is moloney technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study, control | No intervention | –Control: Only modified shouldice repair performed Study: Modified Shouldice + Moloney repairs performed |
| modified shouldice and double | No intervention | Procedure: modified shouldice and doubleone arm is only modified shouldice, other one is double |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Inguinal hernia
Key exclusion criteria (1 listed)
- Recurrences, child
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 |
|---|---|---|
| modified shouldice and doubleAlso: control group, study groupone arm modified shouldice, other one is double repair | Procedure or surgery | modified shouldice and double |
Primary outcome
complications, recurrences
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2011.
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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.
Arslan Kaygusuz, surgeon study chair
S.B. Istanbul Educational & Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified shouldice and double in people with Hernia, run by SB Istanbul Education and Research 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 May 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact erhan mr aysan, assoc. prof. (+902125884400, dr@webcerrah.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications, recurrences (time frame: 6 month). 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 4 May 2011.