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OpenTrials
Completed

NCT Number: NCT01141335

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

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.

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Key information

Conditions

Physical Function Disease Attributes Hernia Infections Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complication Postoperative Complications Recurrence Signs and Symptoms Wound Infection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea

Rome, Italy, 00189

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polypropylene mesh

Device

A Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0.

Infinit® PTFE mesh (WL Gore)

Device

A Lichtenstein tension-free hernioplasty is performed using a PTFE mesh will be fixed by sutures in PTFE 2/0.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Infinit® PTFE Mesh, a Prospective Randomized, Double-blind, Controlled Trial

Important dates

Study start
2009
Primary completion
2010
Study completion
2015
First posted
Jun 10, 2010
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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