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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141335
• Other study ID #: DS-002
• Status: Completed
• Phase: Phase 4
• First received: June 9, 2010
• Last updated: November 20, 2016
• Start date: September 2009
• Est. completion date: September 2015

Study information

• Verified date: November 2016
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: II Faculty of Medicine and Surgery, University Sapienza of Rome
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2015
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Pain
• Physical Function
• Postoperative Complication
• Postoperative Complications
• Recurrence
• Wound Infection

Intervention

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

Locations

Country	Name	City	State
Italy	UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours	No
Secondary	physical function	to measure the physical function score from the SF-36 questionnaire	24 hours	No
Secondary	postoperative acute discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	24 hours	No
Secondary	wound infection	to rate the wound infection risk.	7 days	No
Secondary	postoperative complication	to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.	from 24 hours to 5 years	No
Secondary	recurrence	to measure the recurrence	from 1 months to 5 years	No
Secondary	mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	14 days	No
Secondary	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	72 hours	No
Secondary	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	7 days	No
Secondary	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	14 days	No
Secondary	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	1 months	No
Secondary	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	3 months	No
Secondary	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	6 months	No
Secondary	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	1 year	No
Secondary	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	2 years	No
Secondary	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	3 years	No
Secondary	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	4 years	No
Secondary	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	5 years	No
Secondary	physical function	to measure the physical function score from the SF-36 questionnaire	72 hours	No
Secondary	physical function	to measure the physical function score from the SF-36 questionnaire	7 days	No
Secondary	physical function	to measure the physical function score from the SF-36 questionnaire	14 days	No
Secondary	physical function	to measure the physical function score from the SF-36 questionnaire	1 months	No
Secondary	physical function	to measure the physical function score from the SF-36 questionnaire	3 months	No
Secondary	physical function	to measure the physical function score from the SF-36 questionnaire	6 months	No
Secondary	physical function	to measure the physical function score from the SF-36 questionnaire	1 year	No
Secondary	physical function	to measure the physical function score from the SF-36 questionnaire	2 years	No
Secondary	physical function	to measure the physical function score from the SF-36 questionnaire	3 years	No
Secondary	physical function	to measure the physical function score from the SF-36 questionnaire	4 years	No
Secondary	physical function	to measure the physical function score from the SF-36 questionnaire	5 years	No
Secondary	postoperative acute discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	72 hours	No
Secondary	postoperative acute discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	14 days	No
Secondary	postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	1 months	No
Secondary	postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	3 months	No
Secondary	postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	6 months	No
Secondary	postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	1 year	No
Secondary	postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	2 years	No
Secondary	postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	3 years	No
Secondary	postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	4 years	No
Secondary	postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	5 years	No
Secondary	postoperative acute and chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	7 days	No
Secondary	wound infection	to rate the wound infection risk.	14 days	No
Secondary	wound infection	to rate the wound infection risk.	1 months	No
Secondary	wound infection	to rate the wound infection risk.	3 months	No
Secondary	wound infection	to rate the wound infection risk.	6 months	No
Secondary	wound infection	to rate the wound infection risk.	1 year	No
Secondary	wound infection	to rate the wound infection risk.	2 years	No
Secondary	wound infection	to rate the wound infection risk.	3 years	No
Secondary	wound infection	to rate the wound infection risk.	4 years	No
Secondary	wound infection	to rate the wound infection risk.	5 years	No
Secondary	mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	1 months	No
Secondary	mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	3 months	No
Secondary	mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	6 months	No
Secondary	mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	1 years	No
Secondary	mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	2 years	No
Secondary	mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	3 years	No
Secondary	mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	4 years	No
Secondary	mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	5 years	No