Dynamic Scaffold Versus Lichtenstein Open Hernioplasty.

Inguinal Hernia Clinical Trial

— DYSLOH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05706662
• Other study ID #: DySLOH
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• inguinal hernia repair with mesh
inguinal hernia repair with mesh

Locations

Country	Name	City	State
Italy	University of Palermo	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early postoperative complications	bleeding, hematoma and infections	30 days after surgery
Primary	patients clinical outcome	VAS score	24 months
Secondary	evaluation of quality of life during the postoperative period	Carolina Comfort Scale - CCS	24 months