Physical FunctionPhase 4NCT01141335
Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair
A Phase 4 study testing polypropylene mesh and Infinit® PTFE mesh (WL Gore) in people with Physical Function and Pain, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using Infinit® PTFE Mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Physical Function, Pain, Hernia
- What is being tested?
- polypropylene mesh and Infinit® PTFE mesh (WL Gore)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2009to Sep 2015
- Phase
- Phase 4
- 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
- >18 <65 years of age
- Diagnosis of Unilateral inguinal hernia
- Able to provide written consent
- BMI < 35
- ASA I-II patients
- Non-complicated primary inguinal hernia performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty
- Informed consent
Who cannot join
- Recurrent hernias
- Incarcerated hernia
- BMI > 35
- ASA III-IV patients
- Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient, drug addicted)
- Hypersensitivity to any drug in study
- Patients with an intra-operative findings of different pathology will be excluded from the study
Trial locations and contacts
1 site in 1 country.
Italy1 site
UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea
Rome, Italy, 00189
About this study
Official title: Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Infinit® PTFE Mesh, a Prospective Randomized, Double-blind, Controlled Trial
To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using Infinit® PTFE Mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh.
- Conditions
- Physical Function, Pain, Hernia, Wound Infection, Postoperative Complication, Recurrence
- Being tested
- polypropylene mesh, Infinit® PTFE mesh (WL Gore)
- Keywords
- shrinkage, postoperative pain and discomfort
- Medical subject headings
- Pain, Hernia, Wound Infection, Postoperative Complications, Recurrence, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polypropylene meshDevice
A Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0.
Infinit® PTFE mesh (WL Gore)Device
A Lichtenstein tension-free hernioplasty is performed using a PTFE mesh will be fixed by sutures in PTFE 2/0.
| Study group | Role | What they receive |
|---|---|---|
| PTFE mesh | Experimental | A Lichtenstein tension-free hernioplasty is performed using PTFE mesh Receives: Device: Infinit® PTFE mesh (WL Gore) |
| polypropylene mesh | Active comparator | A Lichtenstein tension-free hernioplasty is performed using polypropylene mesh Receives: Device: polypropylene mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-hernioplasty acute pain
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
Measured: 24 hours
Secondary outcomes (56)
physical function
to measure the physical function score from the SF-36 questionnaire
Measured: 24 hours
postoperative acute discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Measured: 24 hours
wound infection
to rate the wound infection risk.
Measured: 7 days
postoperative complication
to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.
Measured: from 24 hours to 5 years
recurrence
to measure the recurrence
Measured: from 1 months to 5 years
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Measured: 14 days
post-hernioplasty acute pain
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
Measured: 72 hours
post-hernioplasty acute pain
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
Measured: 7 days
post-hernioplasty acute pain
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
Measured: 14 days
post-hernioplasty chronic pain
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
Measured: 1 months
post-hernioplasty chronic pain
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
Measured: 3 months
post-hernioplasty chronic pain
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
Measured: 6 months
post-hernioplasty chronic pain
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
Measured: 1 year
post-hernioplasty chronic pain
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
Measured: 2 years
post-hernioplasty chronic pain
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
Measured: 3 years
post-hernioplasty chronic pain
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
Measured: 4 years
post-hernioplasty chronic pain
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
Measured: 5 years
physical function
to measure the physical function score from the SF-36 questionnaire
Measured: 72 hours
physical function
to measure the physical function score from the SF-36 questionnaire
Measured: 7 days
physical function
to measure the physical function score from the SF-36 questionnaire
Measured: 14 days
physical function
to measure the physical function score from the SF-36 questionnaire
Measured: 1 months
physical function
to measure the physical function score from the SF-36 questionnaire
Measured: 3 months
physical function
to measure the physical function score from the SF-36 questionnaire
Measured: 6 months
physical function
to measure the physical function score from the SF-36 questionnaire
Measured: 1 year
physical function
to measure the physical function score from the SF-36 questionnaire
Measured: 2 years
physical function
to measure the physical function score from the SF-36 questionnaire
Measured: 3 years
physical function
to measure the physical function score from the SF-36 questionnaire
Measured: 4 years
physical function
to measure the physical function score from the SF-36 questionnaire
Measured: 5 years
postoperative acute discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Measured: 72 hours
postoperative acute discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Measured: 14 days
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Measured: 1 months
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Measured: 3 months
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Measured: 6 months
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Measured: 1 year
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Measured: 2 years
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Measured: 3 years
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Measured: 4 years
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Measured: 5 years
postoperative acute and chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Measured: 7 days
wound infection
to rate the wound infection risk.
Measured: 14 days
wound infection
to rate the wound infection risk.
Measured: 1 months
wound infection
to rate the wound infection risk.
Measured: 3 months
wound infection
to rate the wound infection risk.
Measured: 6 months
wound infection
to rate the wound infection risk.
Measured: 1 year
wound infection
to rate the wound infection risk.
Measured: 2 years
wound infection
to rate the wound infection risk.
Measured: 3 years
wound infection
to rate the wound infection risk.
Measured: 4 years
wound infection
to rate the wound infection risk.
Measured: 5 years
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Measured: 1 months
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Measured: 3 months
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Measured: 6 months
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Measured: 1 years
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Measured: 2 years
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Measured: 3 years
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Measured: 4 years
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical FunctionStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Saverio Mari, University of Roma La Sapienza
- Investigators
- Luigi Masoni, Dr., Study chair, Azienda Ospedaliera Sant'Andrea, Rome, ItalyFrancesco Saverio Mari, Dr., Principal investigator, Azienda Ospedaliera Sant'Andrea, Rome, ItalyAntonio Brescia, Prof., Study director, Azienda Ospedaliera Sant'Andrea, Rome, ItalyGiuseppe R Nigri, Dr., Principal investigator, Azienda Ospedaliera Sant'Andrea, Rome, ItalyFrancesco Favi, Dr, Principal investigator, Azienda Ospedaliera Sant'Andrea, Rome, ItalyAndrea Milillo, Dr., Principal investigator, Azienda Ospedaliera Sant'Andrea, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141335
- Sponsor's protocol ID
- DS-002
- Status last verified
- Nov 2016
- First submitted
- 9 Jun 2010
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Infinit® PTFE Mesh, a Prospective Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT01141335
- Acronym / sponsor ID
- DS-002
- Conditions
- Physical Function, Pain, Hernia, Wound Infection, Postoperative Complication, Recurrence
- Keywords
- shrinkage, postoperative pain and discomfort
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Jun 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.
To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using Infinit® PTFE Mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTFE mesh | Experimental | Device: Infinit® PTFE mesh (WL Gore)A Lichtenstein tension-free hernioplasty is performed using PTFE mesh |
| polypropylene mesh | Active comparator | Device: polypropylene meshA Lichtenstein tension-free hernioplasty is performed using polypropylene mesh |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >18 <65 years of age
- Diagnosis of Unilateral inguinal hernia
- Able to provide written consent
- BMI < 35
- ASA I-II patients
Key exclusion criteria (7 listed)
- Recurrent hernias
- Incarcerated hernia
- BMI > 35
- ASA III-IV patients
- Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient, drug addicted)
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 |
|---|---|---|
| polypropylene meshA Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0. | Device | polypropylene mesh |
| Infinit® PTFE mesh (WL Gore)A Lichtenstein tension-free hernioplasty is performed using a PTFE mesh will be fixed by sutures in PTFE 2/0. | Device | PTFE mesh |
Primary outcome
post-hernioplasty acute pain
Time frame: 24 hours
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
56 secondary outcomes
physical function
Time frame: 24 hours
postoperative acute discomfort
Time frame: 24 hours
wound infection
Time frame: 7 days
postoperative complication
Time frame: from 24 hours to 5 years
recurrence
Time frame: from 1 months to 5 years
mesh shrinkage
Time frame: 14 days
post-hernioplasty acute pain
Time frame: 72 hours
post-hernioplasty acute pain
Time frame: 7 days
post-hernioplasty acute pain
Time frame: 14 days
post-hernioplasty chronic pain
Time frame: 1 months
post-hernioplasty chronic pain
Time frame: 3 months
post-hernioplasty chronic pain
Time frame: 6 months
post-hernioplasty chronic pain
Time frame: 1 year
post-hernioplasty chronic pain
Time frame: 2 years
post-hernioplasty chronic pain
Time frame: 3 years
post-hernioplasty chronic pain
Time frame: 4 years
post-hernioplasty chronic pain
Time frame: 5 years
physical function
Time frame: 72 hours
physical function
Time frame: 7 days
physical function
Time frame: 14 days
physical function
Time frame: 1 months
physical function
Time frame: 3 months
physical function
Time frame: 6 months
physical function
Time frame: 1 year
physical function
Time frame: 2 years
physical function
Time frame: 3 years
physical function
Time frame: 4 years
physical function
Time frame: 5 years
postoperative acute discomfort
Time frame: 72 hours
postoperative acute discomfort
Time frame: 14 days
postoperative chronic discomfort
Time frame: 1 months
postoperative chronic discomfort
Time frame: 3 months
postoperative chronic discomfort
Time frame: 6 months
postoperative chronic discomfort
Time frame: 1 year
postoperative chronic discomfort
Time frame: 2 years
postoperative chronic discomfort
Time frame: 3 years
postoperative chronic discomfort
Time frame: 4 years
postoperative chronic discomfort
Time frame: 5 years
postoperative acute and chronic discomfort
Time frame: 7 days
wound infection
Time frame: 14 days
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 22 Nov 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.
Luigi Masoni, Dr. study chair
Azienda Ospedaliera Sant'Andrea, Rome, Italy
Francesco Saverio Mari, Dr. principal investigator
Azienda Ospedaliera Sant'Andrea, Rome, Italy
Antonio Brescia, Prof. study director
Azienda Ospedaliera Sant'Andrea, Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing polypropylene mesh and Infinit® PTFE mesh (WL Gore) in people with Physical Function and Pain, run by University of Roma La Sapienza at 1 site in Italy.
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 7 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: finished, as of the sponsor's last update on 22 Nov 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
post-hernioplasty acute pain (time frame: 24 hours). 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 Nov 2016.