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Dynamic Scaffold Versus Lichtenstein Open Hernioplasty.

NCT ID: NCT05706662

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-12-31

Brief Summary

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Evaluating the outcomes of patients undergoing open anterior inguinal hernioplasty comparing two different techniques: Lichtenstein/plug and mesh and ProFlor. The outcomes of these two groups of patients, respectively the Lichtenstein inguinal hernia repair with static flat mesh and the defect obliteration with 3D dynamic scaffold Proflor, are compared in respect to defined variables along stages: intraoperative, early and long term postoperative.

Detailed Description

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Conditions

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Inguinal Hernia

Keywords

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inguinal hernia repair ProFlor technique lichtenstein hernia repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ProFlor

patients underwent to inguinal hernia repair with use of ProFlor dynamic scaffold

Group Type EXPERIMENTAL

inguinal hernia repair with mesh

Intervention Type PROCEDURE

inguinal hernia repair with mesh

Lichtenstein

patients underwent to Lichtenstein inguinal hernia repair

Group Type ACTIVE_COMPARATOR

inguinal hernia repair with mesh

Intervention Type PROCEDURE

inguinal hernia repair with mesh

Interventions

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inguinal hernia repair with mesh

inguinal hernia repair with mesh

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Eligible patients were individuals aged between 18 and 85 years old, competent to give consent, affected by clinically relevant primary inguinal hernia scheduled to undergo elective inguinal hernia repair and eligible for outpatient surgical procedure with local anesthesia.

Exclusion Criteria

* Recurrent inguinal hernia
* Incarcerated inguinal hernia
* Hernia not in the inguinal area
* Signs of obvious local or systemic infection
* ASA score \> 4
* Presenting with unstable angina or NYHA class of IV
* Pregnant
* Active drug user
* Immunosuppression, chemotherapy
* Chronic renal insufficiency
* Abdominal ascites
* Infection in area of the surgical field
* BMI \>35
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Palermo

OTHER

Sponsor Role lead

Responsible Party

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Prof. Antonino Agrusa

full professor of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Palermo

Palermo, , Italy

Site Status

Countries

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Italy

Other Identifiers

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DySLOH

Identifier Type: -

Identifier Source: org_study_id