Inguinal HerniasNCT01090219
Polypropylene Meshes in Hernia Repair
A study testing two different meshes in the repair of inguinal hernias in people with Inguinal Hernias, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 2 sites in Brazil.
Trial summary
The aim of this study was to analyze the shrinkage of two different screens in the repair of inguinal hernias in men . 32 patients with unilateral inguinal hernia were assigned randomly. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Inguinal Hernias
- What is being tested?
- two different meshes in the repair of inguinal hernias
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesBrazil
- Study dates
- Feb 2008to Jul 2010
- 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 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Elective Surgery
- Men with unilateral inguinal hernia
- Age 20 - 50 years
Who cannot join
- BMI> 30
- Recurrent inguinal hernia
- Strangulated inguinal hernia
- Anesthetic risk ASA III and IV
- Diabetics
- COPD
- Benign prostatic hypertrophy
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
São José Hospital
Criciúma, Santa Catarina
Alexandre C Silvestre, physician, +55 48 34312671
- Recruiting
Universidade do Extremo Sul Catarinense
Criciúma, Santa Catarina
Maria I Rosa, Ph.D., +55 48 34339976, mir@unesc.net
Alexandre C Silvestre, physician
About this study
Official title: Morphofunctional Evaluations of Heavyweight and Ultralightweight Polypropylene Meshes in Men Inguinal Hernia Repair
The aim of this study was to analyze the shrinkage of two different screens in the repair of inguinal hernias in men . 32 patients with unilateral inguinal hernia were assigned randomly. A Lichtenstein tension-free hernia repair was accomplished by emplacing heavy weight versus ultralight weight polypropylene meshes for repair of incisional hernia, marked next to the lips with six titanium clips (LT200).
Read the detailed description
eligibility criteria : Elective Surgery, men with unilateral inguinal hernia, 20 - 50 years Exclusion criteria: BMI> 30, recurrent inguinal hernia, strangulated inguinal hernia, anesthetic risk ASA III and IV, Diabetics, COPD, benign prostatic hypertrophy,cancer disease
outcome: Percentage of contraction of the different meshes by digital radiography in post-surgical days: 1, 30, 60 and 90
Independent variables: age, BMI, smoking, ethnicity, profession
- Conditions
- Inguinal Hernias
- Being tested
- two different meshes in the repair of inguinal hernias
- Keywords
- Inguinal Hernia, contraction of two different meshes in the repair of inguinal hernias in men
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two different meshes in the repair of inguinal herniasProcedure or surgery
A Lichtenstein tension-free hernia repair was accomplished by emplacing Heavy-weight versus low-weight polypropylene meshes for repair of incisional hernia, marked next to the lips with six titanium clips (LT200)
| Study group | Role | What they receive |
|---|---|---|
| two differents meshes | Experimental | Heavy-weight versus low-weight polypropylene meshes Receives: Procedure: two different meshes in the repair of inguinal hernias |
What is being measured
The primary outcome is the main question the study is designed to answer.
contraction of two different meshes in the repair of inguinal hernias in men
Measured: digital radiography in post-surgical days: 1, 30, 60 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startFeb 2008
- Primary completionFeb 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniasStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090219
- Sponsor's protocol ID
- 0002.0.379.174.08
- Status last verified
- Feb 2008
- First submitted
- 18 Mar 2010
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphofunctional Evaluations of Heavyweight and Ultralightweight Polypropylene Meshes in Men Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT01090219
- Acronym / sponsor ID
- 0002.0.379.174.08
- Conditions
- Inguinal Hernias
- Keywords
- Inguinal Hernia, contraction of two different meshes in the repair of inguinal hernias in men
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da SaudeUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 19 Mar 2010 (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 this study was to analyze the shrinkage of two different screens in the repair of inguinal hernias in men . 32 patients with unilateral inguinal hernia were assigned randomly. A Lichtenstein tension-free hernia repair was accomplished by emplacing heavy weight versus ultralight weight polypropylene meshes for repair of incisional hernia, marked next to the lips with six titanium clips (LT200).
Detailed description
eligibility criteria : Elective Surgery, men with unilateral inguinal hernia, 20 - 50 years Exclusion criteria: BMI> 30, recurrent inguinal hernia, strangulated inguinal hernia, anesthetic risk ASA III and IV, Diabetics, COPD, benign prostatic hypertrophy,cancer disease
outcome: Percentage of contraction of the different meshes by digital radiography in post-surgical days: 1, 30, 60 and 90
Independent variables: age, BMI, smoking, ethnicity, profession
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| two differents meshes | Experimental | Procedure: two different meshes in the repair of inguinal herniasHeavy-weight versus low-weight polypropylene meshes |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Elective Surgery
- Men with unilateral inguinal hernia
- Age 20 - 50 years
Key exclusion criteria (7 listed)
- BMI> 30
- Recurrent inguinal hernia
- Strangulated inguinal hernia
- Anesthetic risk ASA III and IV
- Diabetics
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 |
|---|---|---|
| two different meshes in the repair of inguinal herniasA Lichtenstein tension-free hernia repair was accomplished by emplacing Heavy-weight versus low-weight polypropylene meshes for repair of incisional hernia, marked next to the lips with six titanium clips (LT200) | Procedure or surgery | two differents meshes |
Primary outcome
contraction of two different meshes in the repair of inguinal hernias in men
Time frame: digital radiography in post-surgical days: 1, 30, 60 and 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2010.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing two different meshes in the repair of inguinal hernias in people with Inguinal Hernias, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 2 sites in Brazil.
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 7 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 19 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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 Maria I Rosa, Ph.D. (+5548 34339976, mir@unesc.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
contraction of two different meshes in the repair of inguinal hernias in men (time frame: digital radiography in post-surgical days: 1, 30, 60 and 90). 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 19 Mar 2010.