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Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair

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ClinicalTrials.gov Identifier: NCT01141335
Recruitment Status : Completed
First Posted : June 10, 2010
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Physical Function Pain Hernia Wound Infection Postoperative Complication Recurrence Device: polypropylene mesh Device: Infinit® PTFE mesh (WL Gore) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Infinit® PTFE Mesh, a Prospective Randomized, Double-blind, Controlled Trial
Study Start Date : September 2009
Primary Completion Date : September 2010
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: PTFE mesh
A Lichtenstein tension-free hernioplasty is performed using PTFE mesh
Device: 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.
Active Comparator: polypropylene mesh
A Lichtenstein tension-free hernioplasty is performed using polypropylene mesh
Device: polypropylene mesh
A Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0.


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. physical function [ Time Frame: 24 hours ]
    to measure the physical function score from the SF-36 questionnaire

  2. postoperative acute discomfort [ Time Frame: 24 hours ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  3. wound infection [ Time Frame: 7 days ]
    to rate the wound infection risk.

  4. postoperative complication [ Time Frame: from 24 hours to 5 years ]
    to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.

  5. recurrence [ Time Frame: from 1 months to 5 years ]
    to measure the recurrence

  6. mesh shrinkage [ Time Frame: 14 days ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  7. post-hernioplasty acute pain [ Time Frame: 72 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

  8. post-hernioplasty acute pain [ Time Frame: 7 days ]
    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

  9. post-hernioplasty acute pain [ Time Frame: 14 days ]
    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

  10. post-hernioplasty chronic pain [ Time Frame: 1 months ]
    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

  11. post-hernioplasty chronic pain [ Time Frame: 3 months ]
    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

  12. post-hernioplasty chronic pain [ Time Frame: 6 months ]
    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

  13. post-hernioplasty chronic pain [ Time Frame: 1 year ]
    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

  14. post-hernioplasty chronic pain [ Time Frame: 2 years ]
    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

  15. post-hernioplasty chronic pain [ Time Frame: 3 years ]
    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

  16. post-hernioplasty chronic pain [ Time Frame: 4 years ]
    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

  17. post-hernioplasty chronic pain [ Time Frame: 5 years ]
    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

  18. physical function [ Time Frame: 72 hours ]
    to measure the physical function score from the SF-36 questionnaire

  19. physical function [ Time Frame: 7 days ]
    to measure the physical function score from the SF-36 questionnaire

  20. physical function [ Time Frame: 14 days ]
    to measure the physical function score from the SF-36 questionnaire

  21. physical function [ Time Frame: 1 months ]
    to measure the physical function score from the SF-36 questionnaire

  22. physical function [ Time Frame: 3 months ]
    to measure the physical function score from the SF-36 questionnaire

  23. physical function [ Time Frame: 6 months ]
    to measure the physical function score from the SF-36 questionnaire

  24. physical function [ Time Frame: 1 year ]
    to measure the physical function score from the SF-36 questionnaire

  25. physical function [ Time Frame: 2 years ]
    to measure the physical function score from the SF-36 questionnaire

  26. physical function [ Time Frame: 3 years ]
    to measure the physical function score from the SF-36 questionnaire

  27. physical function [ Time Frame: 4 years ]
    to measure the physical function score from the SF-36 questionnaire

  28. physical function [ Time Frame: 5 years ]
    to measure the physical function score from the SF-36 questionnaire

  29. postoperative acute discomfort [ Time Frame: 72 hours ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  30. postoperative acute discomfort [ Time Frame: 14 days ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  31. postoperative chronic discomfort [ Time Frame: 1 months ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  32. postoperative chronic discomfort [ Time Frame: 3 months ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  33. postoperative chronic discomfort [ Time Frame: 6 months ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  34. postoperative chronic discomfort [ Time Frame: 1 year ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  35. postoperative chronic discomfort [ Time Frame: 2 years ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  36. postoperative chronic discomfort [ Time Frame: 3 years ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  37. postoperative chronic discomfort [ Time Frame: 4 years ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  38. postoperative chronic discomfort [ Time Frame: 5 years ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  39. postoperative acute and chronic discomfort [ Time Frame: 7 days ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  40. wound infection [ Time Frame: 14 days ]
    to rate the wound infection risk.

  41. wound infection [ Time Frame: 1 months ]
    to rate the wound infection risk.

  42. wound infection [ Time Frame: 3 months ]
    to rate the wound infection risk.

  43. wound infection [ Time Frame: 6 months ]
    to rate the wound infection risk.

  44. wound infection [ Time Frame: 1 year ]
    to rate the wound infection risk.

  45. wound infection [ Time Frame: 2 years ]
    to rate the wound infection risk.

  46. wound infection [ Time Frame: 3 years ]
    to rate the wound infection risk.

  47. wound infection [ Time Frame: 4 years ]
    to rate the wound infection risk.

  48. wound infection [ Time Frame: 5 years ]
    to rate the wound infection risk.

  49. mesh shrinkage [ Time Frame: 1 months ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  50. mesh shrinkage [ Time Frame: 3 months ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  51. mesh shrinkage [ Time Frame: 6 months ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  52. mesh shrinkage [ Time Frame: 1 years ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  53. mesh shrinkage [ Time Frame: 2 years ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  54. mesh shrinkage [ Time Frame: 3 years ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  55. mesh shrinkage [ Time Frame: 4 years ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  56. mesh shrinkage [ Time Frame: 5 years ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141335


Locations
Italy
UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea
Rome, Italy, 00189
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Study Chair: Luigi Masoni, Dr. Azienda Ospedaliera Sant'Andrea, Rome, Italy
Principal Investigator: Francesco Saverio Mari, Dr. Azienda Ospedaliera Sant'Andrea, Rome, Italy
Study Director: Antonio Brescia, Prof. Azienda Ospedaliera Sant'Andrea, Rome, Italy
Principal Investigator: Giuseppe R Nigri, Dr. Azienda Ospedaliera Sant'Andrea, Rome, Italy
Principal Investigator: Francesco Favi, Dr Azienda Ospedaliera Sant'Andrea, Rome, Italy
Principal Investigator: Andrea Milillo, Dr. Azienda Ospedaliera Sant'Andrea, Rome, Italy
More Information

Responsible Party: Francesco Saverio Mari, MD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01141335     History of Changes
Other Study ID Numbers: DS-002
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016

Keywords provided by Francesco Saverio Mari, University of Roma La Sapienza:
shrinkage
postoperative pain and discomfort

Additional relevant MeSH terms:
Hernia
Recurrence
Hernia, Inguinal
Postoperative Complications
Wound Infection
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
Hernia, Abdominal
Infection