Hernia, InguinalPhase 4NCT00614419
Prospective Randomized Trial Comparing Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Surgisis
A Phase 4 study testing Prolene Polypropylene Mesh and Surgisis Inguinal Hernia Matrix in people with Hernia, Inguinal, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using the Surgisis ES soft tissue graft, as a 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 years and older, men only
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Prolene Polypropylene Mesh and Surgisis Inguinal Hernia Matrix
- 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
- Jan 2003to Dec 2003
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, adult patients
- ASA I-III patients
- Non-complicated primary inguinal hernia (classification according to Gilbert I-II-III-IV-V-VI, modified. according to Rutkow and Robbins) performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty using polypropylene or Surgisis mesh
- Informed consent
Who cannot join
- Recurrent hernias
- 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.
About this study
Official title: Prospective Randomized, Double-blind, Controlled Trial Comparing Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Surgisis ES Soft Tissue Graft
To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using the Surgisis ES soft tissue graft, as a mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh.
Read the detailed description
Inclusion and Exclusion Criteria
Inclusion criteria:
- Male, adult patients
- ASA I-III patients
- Non-complicated primary inguinal hernia (classification according to Gilbert I-II-III-IV-V-VI, modified. according to Rutkow and Robbins) performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty using polypropylene or Surgisis mesh
- Informed consent
Exclusion criteria
- Recurrent hernias
- 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
Outcomes:
General objectives of the study will be:
- to determine the safety of the Lichtenstein's hernioplasty with Surgisis ES by noting any complications observed intraoperatively and postoperatively
- to determine the efficacy of the Lichtenstein's hernioplasty with Surgisis ES in comparison with the traditional method with polypropylene mesh by noting the grade of postoperative pain, discomfort, quality of life, the rate of wound infection and other complications, and the recurrence rate.
The specific objectives of the study will be:
- to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), simple verbal scale (SVS) and parenteral/oral analgesic consumption in the two groups.
- to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS) and simple verbal scale (SVS).
- to measure the postoperative health general status and quality of life with the Short Form 36 (SF-36) questionnaire.
- to rate the wound infection risk.
- to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.
- to measure the recurrence rate.
- Conditions
- Hernia, Inguinal
- Being tested
- Prolene Polypropylene Mesh, Surgisis Inguinal Hernia Matrix
- Keywords
- Hernioplasty, polypropylene, extracellular matrix, xenograft
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolene Polypropylene MeshDevice
Also called PP
The Lichtenstein tension-free hernioplasty consists of a swatch of polypropylene mesh, partway slit 1 cm from its inferior edge to accommodate the spermatic cord. The mesh is sutured circumferentially to the internal oblique abdominal muscle, the rectus sheath and the shelving edge of the inguinal ligament. The tails of the mesh are drawn around the cord and the inferior edge of each tail is sutured to the inguinal ligament. In case of direct hernias, no effort is made to repair the hernia itself. In indirect hernias the sac is excised, except for sliding hernias. The polypropylene mesh group: in this group of patients the polypropylene mesh will be fixed by the above mentioned sutures in Prolene 3/0.
Surgisis Inguinal Hernia MatrixDevice
Also called SIHM
The Surgisis mesh group: in this group of patients a 7x20cm Surgisis ES Soft Tissue Graft sheet will be used. In sterile manner the sheet will be removed from the peel-open package. The Surgisis sheet will be cut and fashioned as appropriate. Then the pre-shaped sheet will will be placed for at least 10 minutes into a sterile dish with sterile room-temperature normo-saline to be rehydrated. Using aseptic techique, the rehydrated Surgisis sheet will be transferred to the already prepared and dissected inguinal region and will be fixed with PDS II 2/0.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | The Lichtenstein tension-free hernioplasty with polypropylene mesh Receives: Device: Prolene Polypropylene Mesh |
| 2 | Experimental | The Surgisis mesh group: in this group of patients a 7x20cm Surgisis ES Soft Tissue Graft sheet will be used. In sterile manner the sheet will be removed from the peel-open package. The Surgisis sheet will be cut and fashioned as appropriate. Then the pre-shaped sheet will will be placed for at least 10 minutes into a sterile dish with sterile room-temperature normo-saline to be rehydrated. Using aseptic techique, the rehydrated Surgisis sheet will be transferred to the already prepared and dissected inguinal region and will be fixed with PDS II 2/0. Receives: Device: Surgisis Inguinal Hernia Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), simple verbal scale (SVS) and parenteral/oral analgesic consumption in the two groups
Measured: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
Secondary outcomes (4)
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS) and simple verbal scale (SVS).
Measured: 3, 6 months, 1, 2, 3, 4, 5 years
to rate the wound infection risk.
Measured: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.
Measured: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
to measure the recurrence rate
Measured: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2003
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Sponsor type
- University, hospital or other
- Investigators
- Luca Ansaloni, MD, Principal investigator, St.Orsola-malpighi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614419
- Sponsor's protocol ID
- 81/2002/O
- Status last verified
- Mar 2021
- First submitted
- 31 Jan 2008
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized, Double-blind, Controlled Trial Comparing Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Surgisis ES Soft Tissue Graft
- ClinicalTrials.gov ID
- NCT00614419
- Acronym / sponsor ID
- 81/2002/O
- Conditions
- Hernia, Inguinal
- Keywords
- Hernioplasty, polypropylene, extracellular matrix, xenograft
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 13 Feb 2008 (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 the Surgisis ES soft tissue graft, as a mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh.
Detailed description
Inclusion and Exclusion Criteria
Inclusion criteria:
- Male, adult patients
- ASA I-III patients
- Non-complicated primary inguinal hernia (classification according to Gilbert I-II-III-IV-V-VI, modified. according to Rutkow and Robbins) performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty using polypropylene or Surgisis mesh
- Informed consent
Exclusion criteria
- Recurrent hernias
- 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
Outcomes:
General objectives of the study will be:
- to determine the safety of the Lichtenstein's hernioplasty with Surgisis ES by noting any complications observed intraoperatively and postoperatively
- to determine the efficacy of the Lichtenstein's hernioplasty with Surgisis ES in comparison with the traditional method with polypropylene mesh by noting the grade of postoperative pain, discomfort, quality of life, the rate of wound infection and other complications, and the recurrence rate.
The specific objectives of the study will be:
- to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), simple verbal scale (SVS) and parenteral/oral analgesic consumption in the two groups.
- to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS) and simple verbal scale (SVS).
- to measure the postoperative health general status and quality of life with the Short Form 36 (SF-36) questionnaire.
- to rate the wound infection risk.
- to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.
- to measure the recurrence rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Prolene Polypropylene MeshThe Lichtenstein tension-free hernioplasty with polypropylene mesh |
| 2 | Experimental | Device: Surgisis Inguinal Hernia MatrixThe Surgisis mesh group: in this group of patients a 7x20cm Surgisis ES Soft Tissue Graft sheet will be used. In sterile manner the sheet will be removed from the peel-open package. The Surgisis sheet will be cut and fashioned as appropriate. Then the pre-shaped sheet will will be placed for at least 10 minutes into a sterile dish with sterile room-temperature normo-saline to be rehydrated. Using aseptic techique, the rehydrated Surgisis sheet will be transferred to the already prepared and dissected inguinal region and will be fixed with PDS II 2/0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male, adult patients
- ASA I-III patients
- Non-complicated primary inguinal hernia (classification according to Gilbert I-II-III-IV-V-VI, modified. according to Rutkow and Robbins) performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty using polypropylene or Surgisis mesh
- Informed consent
Key exclusion criteria (4 listed)
- Recurrent hernias
- 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
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 |
|---|---|---|
| Prolene Polypropylene MeshAlso: PPThe Lichtenstein tension-free hernioplasty consists of a swatch of polypropylene mesh, partway slit 1 cm from its inferior edge to accommodate the spermatic cord. The mesh is sutured circumferentially to the internal oblique abdominal muscle, the rectus sheath and the shelving edge of the inguinal ligament. The tails of the mesh are drawn around the cord and the inferior edge of each tail is sutured to the inguinal ligament. In case of direct hernias, no effort is made to repair the hernia itself. In indirect hernias the sac is excised, except for sliding hernias. The polypropylene mesh group: in this group of patients the polypropylene mesh will be fixed by the above mentioned sutures in Prolene 3/0. | Device | 1 |
| Surgisis Inguinal Hernia MatrixAlso: SIHMThe Surgisis mesh group: in this group of patients a 7x20cm Surgisis ES Soft Tissue Graft sheet will be used. In sterile manner the sheet will be removed from the peel-open package. The Surgisis sheet will be cut and fashioned as appropriate. Then the pre-shaped sheet will will be placed for at least 10 minutes into a sterile dish with sterile room-temperature normo-saline to be rehydrated. Using aseptic techique, the rehydrated Surgisis sheet will be transferred to the already prepared and dissected inguinal region and will be fixed with PDS II 2/0. | Device | 2 |
Primary outcome
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), simple verbal scale (SVS) and parenteral/oral analgesic consumption in the two groups
Time frame: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
4 secondary outcomes
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS) and simple verbal scale (SVS).
Time frame: 3, 6 months, 1, 2, 3, 4, 5 years
to rate the wound infection risk.
Time frame: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.
Time frame: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
to measure the recurrence rate
Time frame: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
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 18 Mar 2021.
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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.
Luca Ansaloni, MD principal investigator
St.Orsola-malpighi Hospital
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 Prolene Polypropylene Mesh and Surgisis Inguinal Hernia Matrix in people with Hernia, Inguinal, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 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: finished, as of the sponsor's last update on 18 Mar 2021. 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?
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), simple verbal scale (SVS) and parenteral/oral analgesic consumption in the two groups (time frame: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 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 18 Mar 2021.