Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair
Primary Purpose
Physical Function, Pain, Hernia
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
polypropylene mesh
Infinit® PTFE mesh (WL Gore)
Sponsored by
About this trial
This is an interventional treatment trial for Physical Function focused on measuring shrinkage, postoperative pain and discomfort
Eligibility Criteria
Inclusion Criteria:
- >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
Exclusion Criteria:
- 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
Sites / Locations
- UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PTFE mesh
polypropylene mesh
Arm Description
A Lichtenstein tension-free hernioplasty is performed using PTFE mesh
A Lichtenstein tension-free hernioplasty is performed using polypropylene mesh
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
physical function
to measure the physical function score from the SF-36 questionnaire
postoperative acute discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
wound infection
to rate the wound infection risk.
postoperative complication
to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.
recurrence
to measure the recurrence
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
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
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
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
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
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
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
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
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
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
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
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
physical function
to measure the physical function score from the SF-36 questionnaire
physical function
to measure the physical function score from the SF-36 questionnaire
physical function
to measure the physical function score from the SF-36 questionnaire
physical function
to measure the physical function score from the SF-36 questionnaire
physical function
to measure the physical function score from the SF-36 questionnaire
physical function
to measure the physical function score from the SF-36 questionnaire
physical function
to measure the physical function score from the SF-36 questionnaire
physical function
to measure the physical function score from the SF-36 questionnaire
physical function
to measure the physical function score from the SF-36 questionnaire
physical function
to measure the physical function score from the SF-36 questionnaire
physical function
to measure the physical function score from the SF-36 questionnaire
postoperative acute discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
postoperative acute discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
postoperative chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
postoperative acute and chronic discomfort
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
wound infection
to rate the wound infection risk.
wound infection
to rate the wound infection risk.
wound infection
to rate the wound infection risk.
wound infection
to rate the wound infection risk.
wound infection
to rate the wound infection risk.
wound infection
to rate the wound infection risk.
wound infection
to rate the wound infection risk.
wound infection
to rate the wound infection risk.
wound infection
to rate the wound infection risk.
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
mesh shrinkage
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Full Information
NCT ID
NCT01141335
First Posted
June 9, 2010
Last Updated
November 20, 2016
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT01141335
Brief Title
Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair
Official Title
Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Infinit® PTFE Mesh, a Prospective Randomized, Double-blind, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Function, Pain, Hernia, Wound Infection, Postoperative Complication, Recurrence
Keywords
shrinkage, postoperative pain and discomfort
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PTFE mesh
Arm Type
Experimental
Arm Description
A Lichtenstein tension-free hernioplasty is performed using PTFE mesh
Arm Title
polypropylene mesh
Arm Type
Active Comparator
Arm Description
A Lichtenstein tension-free hernioplasty is performed using polypropylene mesh
Intervention Type
Device
Intervention Name(s)
polypropylene mesh
Intervention Description
A Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0.
Intervention Type
Device
Intervention Name(s)
Infinit® PTFE mesh (WL Gore)
Intervention Description
A Lichtenstein tension-free hernioplasty is performed using a PTFE mesh will be fixed by sutures in PTFE 2/0.
Primary Outcome Measure Information:
Title
post-hernioplasty acute pain
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
physical function
Description
to measure the physical function score from the SF-36 questionnaire
Time Frame
24 hours
Title
postoperative acute discomfort
Description
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Time Frame
24 hours
Title
wound infection
Description
to rate the wound infection risk.
Time Frame
7 days
Title
postoperative complication
Description
to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.
Time Frame
from 24 hours to 5 years
Title
recurrence
Description
to measure the recurrence
Time Frame
from 1 months to 5 years
Title
mesh shrinkage
Description
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Time Frame
14 days
Title
post-hernioplasty acute pain
Description
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
Time Frame
72 hours
Title
post-hernioplasty acute pain
Description
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
Time Frame
7 days
Title
post-hernioplasty acute pain
Description
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
Time Frame
14 days
Title
post-hernioplasty chronic pain
Description
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
Time Frame
1 months
Title
post-hernioplasty chronic pain
Description
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
Time Frame
3 months
Title
post-hernioplasty chronic pain
Description
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
Time Frame
6 months
Title
post-hernioplasty chronic pain
Description
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
Time Frame
1 year
Title
post-hernioplasty chronic pain
Description
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
Time Frame
2 years
Title
post-hernioplasty chronic pain
Description
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
Time Frame
3 years
Title
post-hernioplasty chronic pain
Description
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
Time Frame
4 years
Title
post-hernioplasty chronic pain
Description
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
Time Frame
5 years
Title
physical function
Description
to measure the physical function score from the SF-36 questionnaire
Time Frame
72 hours
Title
physical function
Description
to measure the physical function score from the SF-36 questionnaire
Time Frame
7 days
Title
physical function
Description
to measure the physical function score from the SF-36 questionnaire
Time Frame
14 days
Title
physical function
Description
to measure the physical function score from the SF-36 questionnaire
Time Frame
1 months
Title
physical function
Description
to measure the physical function score from the SF-36 questionnaire
Time Frame
3 months
Title
physical function
Description
to measure the physical function score from the SF-36 questionnaire
Time Frame
6 months
Title
physical function
Description
to measure the physical function score from the SF-36 questionnaire
Time Frame
1 year
Title
physical function
Description
to measure the physical function score from the SF-36 questionnaire
Time Frame
2 years
Title
physical function
Description
to measure the physical function score from the SF-36 questionnaire
Time Frame
3 years
Title
physical function
Description
to measure the physical function score from the SF-36 questionnaire
Time Frame
4 years
Title
physical function
Description
to measure the physical function score from the SF-36 questionnaire
Time Frame
5 years
Title
postoperative acute discomfort
Description
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Time Frame
72 hours
Title
postoperative acute discomfort
Description
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Time Frame
14 days
Title
postoperative chronic discomfort
Description
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Time Frame
1 months
Title
postoperative chronic discomfort
Description
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Time Frame
3 months
Title
postoperative chronic discomfort
Description
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Time Frame
6 months
Title
postoperative chronic discomfort
Description
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Time Frame
1 year
Title
postoperative chronic discomfort
Description
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Time Frame
2 years
Title
postoperative chronic discomfort
Description
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Time Frame
3 years
Title
postoperative chronic discomfort
Description
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Time Frame
4 years
Title
postoperative chronic discomfort
Description
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Time Frame
5 years
Title
postoperative acute and chronic discomfort
Description
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
Time Frame
7 days
Title
wound infection
Description
to rate the wound infection risk.
Time Frame
14 days
Title
wound infection
Description
to rate the wound infection risk.
Time Frame
1 months
Title
wound infection
Description
to rate the wound infection risk.
Time Frame
3 months
Title
wound infection
Description
to rate the wound infection risk.
Time Frame
6 months
Title
wound infection
Description
to rate the wound infection risk.
Time Frame
1 year
Title
wound infection
Description
to rate the wound infection risk.
Time Frame
2 years
Title
wound infection
Description
to rate the wound infection risk.
Time Frame
3 years
Title
wound infection
Description
to rate the wound infection risk.
Time Frame
4 years
Title
wound infection
Description
to rate the wound infection risk.
Time Frame
5 years
Title
mesh shrinkage
Description
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Time Frame
1 months
Title
mesh shrinkage
Description
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Time Frame
3 months
Title
mesh shrinkage
Description
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Time Frame
6 months
Title
mesh shrinkage
Description
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Time Frame
1 years
Title
mesh shrinkage
Description
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Time Frame
2 years
Title
mesh shrinkage
Description
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Time Frame
3 years
Title
mesh shrinkage
Description
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Time Frame
4 years
Title
mesh shrinkage
Description
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Masoni, Dr.
Organizational Affiliation
Azienda Ospedaliera Sant'Andrea, Rome, Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francesco Saverio Mari, Dr.
Organizational Affiliation
Azienda Ospedaliera Sant'Andrea, Rome, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Brescia, Prof.
Organizational Affiliation
Azienda Ospedaliera Sant'Andrea, Rome, Italy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Giuseppe R Nigri, Dr.
Organizational Affiliation
Azienda Ospedaliera Sant'Andrea, Rome, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Favi, Dr
Organizational Affiliation
Azienda Ospedaliera Sant'Andrea, Rome, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Milillo, Dr.
Organizational Affiliation
Azienda Ospedaliera Sant'Andrea, Rome, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea
City
Rome
ZIP/Postal Code
00189
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair
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