Dynamic Scaffold Versus Lichtenstein Open Hernioplasty. (DYSLOH)

January 21, 2023 updated by: Prof. Antonino Agrusa, University of Palermo

The DySLOH Study: Dynamic Scaffold Versus Lichtenstein Open Hernioplasty. A Comparative Outcome Assessment Between the Two Techniques.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy, 90127
        • University of Palermo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ProFlor
patients underwent to inguinal hernia repair with use of ProFlor dynamic scaffold
Procedure: inguinal hernia repair with mesh
inguinal hernia repair with mesh
ACTIVE_COMPARATOR: Lichtenstein
patients underwent to Lichtenstein inguinal hernia repair
Procedure: inguinal hernia repair with mesh
inguinal hernia repair with mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early postoperative complications
Time Frame: 30 days after surgery
bleeding, hematoma and infections
30 days after surgery
patients clinical outcome
Time Frame: 24 months
VAS score
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of quality of life during the postoperative period
Time Frame: 24 months
Carolina Comfort Scale - CCS
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Palermo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

January 21, 2023

First Submitted That Met QC Criteria

January 21, 2023

First Posted (ACTUAL)

January 31, 2023

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 21, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DySLOH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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