Study on Ultrapro vs Polypropylene: Early Results From a Multicentric Experience in Surgery for Hernia

A Multicenter Prospective Randomized Study Of Comparison Between Semi-Absorbable Prosthesis And Totally Nonabsorbable Prosthesis In Inguinal Hernia Surgery

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02666040

Acronym

SUPERMESH

Enrollment

1200

Registered

2016-01-28

Start date

2009-11-30

Completion date

2016-03-31

Last updated

2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Brief summary

With reference to inguinal hernia surgeries with prosthesis, the multicenter study aims to investigate the benefits in terms of incidence of pain and discomfort, improvement in the quality of life for the patient after the use of the newly introduced semi-absorbable prosthesis (ULTRAPRO® meshes) compared with the prosthesis of totally nonabsorbable material (conventional meshes in polypropylene Prolene®), and in terms of the costs for the hospital, the National Health System (NHS), and the society of associates for the use of the ULTRAPRO® in inguinal hernia surgeries.

Interventions

DEVICEULTRAPRO® meshes

The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.

DEVICEProlene® meshes

The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.

PROCEDUREDetecting the mode of admission to hospital

Ordinary admission or day surgery

PROCEDUREDuration of surgery

Time operating room

PROCEDUREAnesthesia volume and type used

Anesthesias used: infiltration, followed by spinal, general, epidural.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Elective surgery * Males and females * Adults over 18 * All primitive inguinal hernia

Exclusion criteria

* Emergency surgery * Impossibility to complete the follow-up * Patients with acquired immunodeficiency symptoms * Patients with relapsed inguinal hernia

Design outcomes

Primary

Measure	Time frame	Description
Chronic pain or discomfort evaluated at 6 months, by Visual Analogic Scale for pain (VAS)	6 months after the operation	VAS is a horizontal line, 100 mm in length, anchored by word descriptors (no pain, very severe pain) at each end.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026