Inguinal Hernia
Conditions
Keywords
inguinal hernia repair, ProFlor technique, lichtenstein hernia repair
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.
Interventions
PROCEDUREinguinal hernia repair with mesh
inguinal hernia repair with mesh
Sponsors
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| patients clinical outcome | 24 months | VAS score |
| early postoperative complications | 30 days after surgery | bleeding, hematoma and infections |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of quality of life during the postoperative period | 24 months | Carolina Comfort Scale - CCS |
Countries
Italy
Outcome results
None listed