NCT02666040

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable chronic-pain

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

6.2 years

First QC Date

January 14, 2016

Last Update Submit

January 25, 2016

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Chronic pain or discomfort evaluated at 6 months, by Visual Analogic Scale for pain (VAS)

    VAS is a horizontal line, 100 mm in length, anchored by word descriptors (no pain, very severe pain) at each end.

    6 months after the operation

Study Arms (2)

U - ULTRAPRO

EXPERIMENTAL

Inguinal Hernia Surgery with ULTRAPRO® meshes, a new ULTRAPRO® mesh will be implanted in patients in the group (AG). The surgery will be evaluated in terms of procedure, detecting the mode of admission to hospital, the duration of surgery, anesthesia volume and type used, composition of the surgical equipment.

Device: ULTRAPRO® meshesProcedure: Detecting the mode of admission to hospitalProcedure: Duration of surgeryProcedure: Anesthesia volume and type used

P - Prolene

ACTIVE COMPARATOR

Inguinal Hernia Surgery with "Prolene®" meshes, the conventional mesh in polypropylene "Prolene®" will be implanted in patients in the control group (CG). The surgery will be evaluated in terms of procedure, detecting the mode of admission to hospital, the duration of surgery, anesthesia volume and type used, composition of the surgical equipment.

Device: "Prolene®" meshesProcedure: Detecting the mode of admission to hospitalProcedure: Duration of surgeryProcedure: Anesthesia volume and type used

Interventions

ULTRAPRO® meshesDEVICE

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

U - ULTRAPRO
"Prolene®" meshesDEVICE

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

P - Prolene
Detecting the mode of admission to hospitalPROCEDURE

Ordinary admission or day surgery

P - ProleneU - ULTRAPRO
Duration of surgeryPROCEDURE

Time operating room

P - ProleneU - ULTRAPRO
Anesthesia volume and type usedPROCEDURE

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

P - ProleneU - ULTRAPRO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marco Montorsi, Prof.

    Humanitas Research Hospital IRCCS, Rozzano-Milan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Coordinator

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 28, 2016

Study Start

November 1, 2009

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

January 28, 2016

Record last verified: 2016-01