Dynamic Scaffold Versus Lichtenstein Open Hernioplasty. (DYSLOH)

University of Palermo

Status: Completed

Conditions: Inguinal Hernia

Treatments: Procedure: inguinal hernia repair with mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT05706662

DySLOH

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

188 participants in 2 patient groups

ProFlor

Experimental group

Description:

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

Treatment:

Procedure: inguinal hernia repair with mesh

Lichtenstein

Active Comparator group

Description:

patients underwent to Lichtenstein inguinal hernia repair

Treatment:

Procedure: inguinal hernia repair with mesh