Prospective Randomized Trial Comparing Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Surgisis

March 17, 2021 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. to determine the safety of the Lichtenstein's hernioplasty with Surgisis ES by noting any complications observed intraoperatively and postoperatively
  2. 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:

  1. 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.
  2. to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS) and simple verbal scale (SVS).
  3. to measure the postoperative health general status and quality of life with the Short Form 36 (SF-36) questionnaire.
  4. to rate the wound infection risk.
  5. to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.
  6. to measure the recurrence rate.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • St.Orsola-Malpighi University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: 1
The Lichtenstein tension-free hernioplasty with polypropylene mesh
Device: Prolene Polypropylene Mesh
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.
Other Names:
  • PP
EXPERIMENTAL: 2
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.
Device: Surgisis Inguinal Hernia Matrix
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.
Other Names:
  • SIHM

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luca Ansaloni, MD, St.Orsola-malpighi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2003

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2003

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2008

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 81/2002/O

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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