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

Not Applicable

• Conditions: Chronic Pain
• Interventions: Device: ULTRAPRO® meshes; Device: "Prolene®" meshes; Procedure: Detecting the mode of admission to hospital; Procedure: Duration of surgery; Procedure: Anesthesia volume and type used

• Registration Number: NCT02666040
• Lead Sponsor: Istituto Clinico Humanitas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-25
• Last Update Submitted: 2016-01-25
• Study First Posted: 2016-01-28
• Last Update Posted: 2016-01-28
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
U - ULTRAPRO	Detecting the mode of admission to hospital	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.
U - ULTRAPRO	Duration of surgery	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.
U - ULTRAPRO	ULTRAPRO® meshes	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.
U - ULTRAPRO	Anesthesia volume and type used	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.
P - Prolene	"Prolene®" meshes	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.
P - Prolene	Detecting the mode of admission to hospital	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.
P - Prolene	Duration of surgery	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.
P - Prolene	Anesthesia volume and type used	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.

Primary Outcome Measures

Name	Time	Method
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.