NCT05706662

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

January 21, 2023

Last Update Submit

January 21, 2023

Conditions

Inguinal Hernia

Keywords

inguinal hernia repairProFlor techniquelichtenstein hernia repair

Outcome Measures

Primary Outcomes (2)

  • early postoperative complications

    bleeding, hematoma and infections

    30 days after surgery

  • patients clinical outcome

    VAS score

    24 months

Secondary Outcomes (1)

  • evaluation of quality of life during the postoperative period

    24 months

Study Arms (2)

ProFlor

EXPERIMENTAL

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

Procedure: inguinal hernia repair with mesh

Lichtenstein

ACTIVE COMPARATOR

patients underwent to Lichtenstein inguinal hernia repair

Procedure: inguinal hernia repair with mesh

Interventions

inguinal hernia repair with meshPROCEDURE

inguinal hernia repair with mesh

LichtensteinProFlor

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Palermo

Palermo, 90127, Italy

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
full professor of surgery

Study Record Dates

First Submitted

January 21, 2023

First Posted

January 31, 2023

Study Start

January 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)