Primary Inguinal HerniaNCT01596049
The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair
An observational study of Primary Inguinal Hernia and Unilateral Hernia, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Primary Inguinal Hernia, Unilateral Hernia, Open Surgery
- What is being tested?
- Self-fixating Mesh
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteIsrael
- Study dates
- May 2012to Aug 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 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: patients who are undergoing Inguinal Hernia Repair Surgery.
Who may be able to join
- All patients undergoing primary unilateral open Inguinal Hernia Repair .
- patients undergoing elective surgery.
- above the age of 18 years old
Who cannot join
- patients having repeated Inguinal Hernia.
- patients having bilateral Hernia.
- patients undergoing laparoscopic surgery.
- patients undergoing non-elective surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair, in Comparison to the Standard Treatment in the Literature
This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia.
The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.
The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).
Read the detailed description
This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia.
The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.
The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).
The data will be compared to the literature and will be statistically analysed. The follow-up for each patient will be two years.
- Conditions
- Primary Inguinal Hernia, Unilateral Hernia, Open Surgery
- Being tested
- Self-fixating Mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-fixating MeshDevice
Using Self-fixating Mesh for Inguinal Hernia Repair
| Study group | Role | What they receive |
|---|---|---|
| Self-fixating Mesh | patients attributed to that arm, undergoing surgery of open inguinal unilateral hernia repair, using Self-fixating Mesh which is acceptable in the literature. Receives: Device: Self-fixating Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of post operative inguinal Hernia recurrence.
Measured: 2 weeks, 3,6,12,24 months post-operative
Post-operative patient quality of life will be assessed using a validated questionnaire.
Measured: 2 weeks, 3,6,12,24 months post-operative
Pain will be assessed by NRS (Numerical Rating Scale)
Measured: 2 weeks, 3,6,12,24 months post-operative
Post-operative complications will be assessed using a validated questionnaire.
Measured: 2 weeks, 3,6,12,24 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: recruitment was not going well.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adel Abu_Salih, M.D, Principal investigator, Rambam health care campus, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596049
- Sponsor's protocol ID
- hernia313-11-RMBCTIL
- Status last verified
- Aug 2017
- First submitted
- 9 May 2012
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair, in Comparison to the Standard Treatment in the Literature
- ClinicalTrials.gov ID
- NCT01596049
- Acronym / sponsor ID
- hernia313-11-RMBCTIL
- Conditions
- Primary Inguinal Hernia, Unilateral Hernia, Open Surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment was not going well.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 10 May 2012 (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 study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia.
The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.
The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).
Detailed description
This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia.
The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.
The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).
The data will be compared to the literature and will be statistically analysed. The follow-up for each patient will be two years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-fixating Mesh | – | Device: Self-fixating Meshpatients attributed to that arm, undergoing surgery of open inguinal unilateral hernia repair, using Self-fixating Mesh which is acceptable in the literature. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who are undergoing Inguinal Hernia Repair Surgery.
Key inclusion criteria (3 listed)
- All patients undergoing primary unilateral open Inguinal Hernia Repair .
- patients undergoing elective surgery.
- above the age of 18 years old
Key exclusion criteria (4 listed)
- patients having repeated Inguinal Hernia.
- patients having bilateral Hernia.
- patients undergoing laparoscopic surgery.
- patients undergoing non-elective surgery.
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 |
|---|---|---|
| Self-fixating MeshUsing Self-fixating Mesh for Inguinal Hernia Repair | Device | Self-fixating Mesh |
Primary outcome
Percentage of post operative inguinal Hernia recurrence.
Time frame: 2 weeks, 3,6,12,24 months post-operative
Post-operative patient quality of life will be assessed using a validated questionnaire.
Time frame: 2 weeks, 3,6,12,24 months post-operative
Pain will be assessed by NRS (Numerical Rating Scale)
Time frame: 2 weeks, 3,6,12,24 months post-operative
Post-operative complications will be assessed using a validated questionnaire.
Time frame: 2 weeks, 3,6,12,24 months post-operative
Results and safety
The study was stopped early (reason given: recruitment was not going well.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
Related trials for Primary Inguinal Hernia
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Recruiting
Desarda Tissue Technique vs Lichtenstein Technique for Primary Inguinal Hernia Repair
Inguinal Hernia Unilateral, Complications of Surgical Procedures or Medical Care
Recruiting
Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair
Indirect Inguinal Hernia
RecruitingObservational study
Prospective Study of Minimally Invasive (Laparoscopic and Robotic) Hernia Repair (Incisional and Primary, Midline and Lateral, Not Inguinal)
Ventral Hernia Midline, Hernia Lumbar
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, M.D principal investigator
Rambam health care campus, Haifa, Israel
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 Primary Inguinal Hernia and Unilateral 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 22 Aug 2017. 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?
The study was stopped early (reason given: recruitment was not going well.). Results are not available in the source record.
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?
Percentage of post operative inguinal Hernia recurrence. (time frame: 2 weeks, 3,6,12,24 months post-operative). The study lists 4 primary outcomes in all. 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 22 Aug 2017.