inguinal hernia
Conditions
Interventions
Biological Mesh (RemodellingTM):open tension-free inguinal hernia repair
Surgisis Inguinal hernia Matrix :open tension-free inguinal hernia repair
Sponsors
Huadong Hospital Affiliated to Fudan Univercity
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Unilateral inguinal hernia diagnosed as Type I-III in accordance with the China Hernia Society Groin Hernia classification (2003) APPENDIX A; (2) Aged 18-75 years; (3) Male; (4) Patients with ASA physical status I-IIIAPPENDIX B; (5) Informed consent: a detailed description of the clinical trial was provided by physicians and an informed consent APPENDIXC was signed by the patient or a proxy decision maker.
Exclusion criteria
Exclusion criteria: (1) Recurrent hernia, incarcerated hernia or bilateral hernia; (2) Any status that might affect the correct evaluation of pains(patient who were noncompliant, blind or drug addicted or have mental illness,e.g., depression); (3) Patients who were allergic to study materials; (4) Surgical contraindications:local infection; abnormality detected in systemic examination; patients with previous history of severe drug allergy or a history of asthma, heart disease, liver disease, kidney disease, diabetes, blood diseases or other severe conditions of acute or chronic diseases; evident abnormality detected in laboratory tests; evident abnormality in blood, clotting and bleeding time, liver function or kidney function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy rate (1-recurrence rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of surgical site infection;Degree of pain in resting and coughing state;Other complications.; | — |
Countries
China
Contacts
Public ContactJianxiong Tang
Huadong Hospital Affiliated to Fudan Univercity
Outcome results
None listed