NCT05706662: DYSLOH

Dynamic Scaffold Versus Lichtenstein Open Hernioplasty.

Completed NA Last updated 31 January 2023

What this trial tests

NA trial testing inguinal hernia repair with mesh in Inguinal Hernia in 188 participants. Completed in 31 December 2022.

Timeline

1 January 2018

Primary endpoint
31 December 2020

31 December 2022

Quick facts

Lead sponsor	University of Palermo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	188
Start date	1 January 2018
Primary completion	31 December 2020
Estimated completion	31 December 2022
Sites	1 location across Italy

Drugs / interventions tested

• inguinal hernia repair with mesh

Conditions studied

• Inguinal Hernia — all drugs for Inguinal Hernia →

Sponsor

University of Palermo

Who can join

Adults 18 to 85, any sex, with Inguinal Hernia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The DySLOH Study: Comparative Evaluation of the Results between the ProFlor and Lichtenstein Techniques for Open Inguinal Hernia Repair-A Randomized Controlled Trial.
   Romano G, Di Buono G, Rodolico V, Romano G, et al · · 2024 · cited 2× · PMID 39337017 · DOI 10.3390/jcm13185530