Chronic PainSUPERMESHNCT02666040
Study on Ultrapro vs Polypropylene: Early Results From a Multicentric Experience in Surgery for Hernia
A study testing ULTRAPRO® meshes, "Prolene®" meshes and Detecting the mode of admission to hospital in people with Chronic Pain, run by Istituto Clinico Humanitas.
Trial summary
With reference to inguinal hernia surgeries with prosthesis, the multicenter study aims to investigate the benefits in terms of incidence of pain and discomfort, improvement in the quality of life for the patient after the use of the newly introduced semi-absorbable prosthesis (ULTRAPRO® meshes) compared with the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- ULTRAPRO® meshes, "Prolene®" meshes and Detecting the mode of admission to hospital
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Mar 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery
- Males and females
- Adults over 18
- All primitive inguinal hernia
Who cannot join
- Emergency surgery
- Impossibility to complete the follow-up
- Patients with acquired immunodeficiency symptoms
- Patients with relapsed inguinal hernia
About this study
Official title: A Multicenter Prospective Randomized Study Of Comparison Between Semi-Absorbable Prosthesis And Totally Nonabsorbable Prosthesis In Inguinal Hernia Surgery
With reference to inguinal hernia surgeries with prosthesis, the multicenter study aims to investigate the benefits in terms of incidence of pain and discomfort, improvement in the quality of life for the patient after the use of the newly introduced semi-absorbable prosthesis (ULTRAPRO® meshes) compared with the prosthesis of totally nonabsorbable material (conventional meshes in polypropylene "Prolene®"), and in terms of the costs for the hospital, the National Health System (NHS), and the society of associates for the use of the ULTRAPRO® in inguinal hernia surgeries.
- Conditions
- Chronic Pain
- Being tested
- ULTRAPRO® meshes, "Prolene®" meshes, Detecting the mode of admission to hospital, Duration of surgery, Anesthesia volume and type used
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULTRAPRO® meshesDevice
The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.
"Prolene®" meshesDevice
The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.
Detecting the mode of admission to hospitalProcedure or surgery
Ordinary admission or day surgery
Duration of surgeryProcedure or surgery
Time operating room
Anesthesia volume and type usedProcedure or surgery
Anesthesias used: infiltration, followed by spinal, general, epidural.
| Study group | Role | What they receive |
|---|---|---|
| U - ULTRAPRO | Experimental | Inguinal Hernia Surgery with ULTRAPRO® meshes, a new ULTRAPRO® mesh will be implanted in patients in the group (AG). The surgery will be evaluated in terms of procedure, detecting the mode of admission to hospital, the duration of surgery, anesthesia volume and type used, composition of the surgical equipment. Receives: Device: ULTRAPRO® meshes; Procedure: Detecting the mode of admission to hospital; Procedure: Duration of surgery; Procedure: Anesthesia volume and type used |
| P - Prolene | Active comparator | Inguinal Hernia Surgery with "Prolene®" meshes, the conventional mesh in polypropylene "Prolene®" will be implanted in patients in the control group (CG). The surgery will be evaluated in terms of procedure, detecting the mode of admission to hospital, the duration of surgery, anesthesia volume and type used, composition of the surgical equipment. Receives: Device: "Prolene®" meshes; Procedure: Detecting the mode of admission to hospital; Procedure: Duration of surgery; Procedure: Anesthesia volume and type used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain or discomfort evaluated at 6 months, by Visual Analogic Scale for pain (VAS)
VAS is a horizontal line, 100 mm in length, anchored by word descriptors (no pain, very severe pain) at each end.
Measured: 6 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startNov 2009
- Primary completionJan 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Zeta Research Ltd
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
- Investigators
- Marco Montorsi, Prof., Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666040
- Sponsor's protocol ID
- 10-v035
- Acronym
- SUPERMESH
- Status last verified
- Jan 2016
- First submitted
- 14 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Randomized Study Of Comparison Between Semi-Absorbable Prosthesis And Totally Nonabsorbable Prosthesis In Inguinal Hernia Surgery
- ClinicalTrials.gov ID
- NCT02666040
- Acronym / sponsor ID
- SUPERMESH / 10-v035
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Zeta Research Ltd
- Study start
- Nov 2009
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 28 Jan 2016 (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.
With reference to inguinal hernia surgeries with prosthesis, the multicenter study aims to investigate the benefits in terms of incidence of pain and discomfort, improvement in the quality of life for the patient after the use of the newly introduced semi-absorbable prosthesis (ULTRAPRO® meshes) compared with the prosthesis of totally nonabsorbable material (conventional meshes in polypropylene "Prolene®"), and in terms of the costs for the hospital, the National Health System (NHS), and the society of associates for the use of the ULTRAPRO® in inguinal hernia surgeries.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| U - ULTRAPRO | Experimental | Device: ULTRAPRO® meshes, Procedure: Detecting the mode of admission to hospital, Procedure: Duration of surgery, Procedure: Anesthesia volume and type usedInguinal Hernia Surgery with ULTRAPRO® meshes, a new ULTRAPRO® mesh will be implanted in patients in the group (AG). The surgery will be evaluated in terms of procedure, detecting the mode of admission to hospital, the duration of surgery, anesthesia volume and type used, composition of the surgical equipment. |
| P - Prolene | Active comparator | Device: "Prolene®" meshes, Procedure: Detecting the mode of admission to hospital, Procedure: Duration of surgery, Procedure: Anesthesia volume and type usedInguinal Hernia Surgery with "Prolene®" meshes, the conventional mesh in polypropylene "Prolene®" will be implanted in patients in the control group (CG). The surgery will be evaluated in terms of procedure, detecting the mode of admission to hospital, the duration of surgery, anesthesia volume and type used, composition of the surgical equipment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective surgery
- Males and females
- Adults over 18
- All primitive inguinal hernia
Key exclusion criteria (4 listed)
- Emergency surgery
- Impossibility to complete the follow-up
- Patients with acquired immunodeficiency symptoms
- Patients with relapsed inguinal hernia
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 |
|---|---|---|
| ULTRAPRO® meshesThe inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug. | Device | U - ULTRAPRO |
| "Prolene®" meshesThe inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug. | Device | P - Prolene |
| Detecting the mode of admission to hospitalOrdinary admission or day surgery | Procedure or surgery | P - Prolene, U - ULTRAPRO |
| Duration of surgeryTime operating room | Procedure or surgery | P - Prolene, U - ULTRAPRO |
| Anesthesia volume and type usedAnesthesias used: infiltration, followed by spinal, general, epidural. | Procedure or surgery | P - Prolene, U - ULTRAPRO |
Primary outcome
Chronic pain or discomfort evaluated at 6 months, by Visual Analogic Scale for pain (VAS)
Time frame: 6 months after the operation
VAS is a horizontal line, 100 mm in length, anchored by word descriptors (no pain, very severe pain) at each end.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 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.
Marco Montorsi, Prof. principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
Questions about this trial
What is this clinical trial studying?
A study testing ULTRAPRO® meshes, "Prolene®" meshes and Detecting the mode of admission to hospital in people with Chronic Pain, run by Istituto Clinico Humanitas.
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 4 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: status not confirmed, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Chronic pain or discomfort evaluated at 6 months, by Visual Analogic Scale for pain (VAS) (time frame: 6 months after the operation). 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 28 Jan 2016.