Inguinal HerniaNCT02507830
Mesh Fixation With a Synthetic Glue in Primary Inguinal Hernia Repair
An observational study of Inguinal Hernia, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Prospective observational study with mesh fixation using FDA approved synthetic glue,glubran 2 and standard mesh fixation with stiches in primary inguinal hernia repair surgery. The investigators aim is to recruit 150 patients for the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2015to Jul 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults older than 18 undergoing a primary inguinal hernia repair
Who may be able to join
- Primary Inguinal hernia
Who cannot join
- Recurrent hernia
- Large inguinoscrotal hernias
- Bilateral inguinal hernias
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus
Haifa
Adel Abu_Salih, M.D, 972-4-8541308, a_abu_salih@rambam.health.gov.il
About this study
Prospective observational study with mesh fixation using FDA approved synthetic glue,glubran 2 and standard mesh fixation with stiches in primary inguinal hernia repair surgery. The investigators aim is to recruit 150 patients for the study.
The outcomes The investigators would like to determine are : postoperative pain,recurrences and complication rates such as seromas.
Read the detailed description
Prospective observational study with mesh fixation using FDA approved synthetic glue,glubran 2 and standard mesh fixation with stiches in primary inguinal hernia repair surgery. The investigators aim is to recruit 150 patients for the study.
The outcomes The investigators would like to determine are : postoperative pain,recurrences and complication rates such as seromas.
- Conditions
- Inguinal Hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Glubran 2 fixation | Mesh fixation with Glubran 2 glue in primary inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain (Evaluation will be conducted through scale and a questionnaire )
Measured: 2 years
Secondary outcomes (2)
Hernia recurrence (Evaluation will be conducted through a questionnaire and physical examination )
Measured: 2 years
Postoperative complications (Evaluation will be conducted through a questionnaire and physical examination )
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adel Abu_Salih, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507830
- Sponsor's protocol ID
- Meshg2
- Status last verified
- Mar 2016
- First submitted
- 20 Jul 2015
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh Fixation With a Synthetic Glue in Primary Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT02507830
- Acronym / sponsor ID
- Meshg2
- Conditions
- Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 24 Jul 2015 (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.
Prospective observational study with mesh fixation using FDA approved synthetic glue,glubran 2 and standard mesh fixation with stiches in primary inguinal hernia repair surgery. The investigators aim is to recruit 150 patients for the study.
The outcomes The investigators would like to determine are : postoperative pain,recurrences and complication rates such as seromas.
Detailed description
Prospective observational study with mesh fixation using FDA approved synthetic glue,glubran 2 and standard mesh fixation with stiches in primary inguinal hernia repair surgery. The investigators aim is to recruit 150 patients for the study.
The outcomes The investigators would like to determine are : postoperative pain,recurrences and complication rates such as seromas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glubran 2 fixation | – | –Mesh fixation with Glubran 2 glue in primary inguinal hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults older than 18 undergoing a primary inguinal hernia repair
Key inclusion criteria (1 listed)
- Primary Inguinal hernia
Key exclusion criteria (3 listed)
- Recurrent hernia
- Large inguinoscrotal hernias
- Bilateral inguinal hernias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative pain (Evaluation will be conducted through scale and a questionnaire )
Time frame: 2 years
2 secondary outcomes
Hernia recurrence (Evaluation will be conducted through a questionnaire and physical examination )
Time frame: 2 years
Postoperative complications (Evaluation will be conducted through a questionnaire and physical examination )
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
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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.
Adel Abu_Salih, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Rambam Health Care Campus at 1 site in Israel.
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 3 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 3 Mar 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 Israel. 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 Adel Abu_Salih, MD (972-4-8541308, a_abu_salih@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (Evaluation will be conducted through scale and a questionnaire ) (time frame: 2 years). 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 3 Mar 2016.