Abdominal Wall Hernia
Conditions
Interventions
1:??????(????)
2:Hernia Graft (US Cook, Biodesign)
Sponsors
Shanghai Pine&Power Biotech Co.,Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients with non-complex abdominal wall hernia diagnosed by clinical manifestations, physical examination and CT, including incisional hernia, white line sputum, umbilical hernia, rectus abdominis separation, and meniscus sputum; 2) Aged 18-75 years; 3) Patients with the American Society of Anesthesiologists score I-III; 4) Informed consent: a detailed description of the clinical trial was provided by physicians and an informed consent was signed by the patient or his agent.
Exclusion criteria
Exclusion criteria: 1) Any situation that affects the correct evaluation of pain (non-cooperative, blind, drug addict, depression or other mental problems or mental illness); 2) Patients who are allergic to the test materials; 3) Patients with complicated abdominal wall hernia: the transverse diameter of the abdominal wall defect is >10 cm; 4) Patients with systemic underlying disease that have not been controlled, or are in an unstable state, or have important organ dysfunction, such as local infection, serious history of drug allergy, history of asthma, heart disease, liver and kidney disease, Diabetes and blood diseases; 5) Patients with infected lesions in the abdominal wall or abdominal cavity, malignant diseases in the abdominal cavity, and patients with signs of tumor recurrence, metastasis or dissemination; 6) BMI = 30, defined as obese patients according to WHO; 7) Patients with malignant tumors with a life expectancy of <12 months; 8) Emergency treatment of patients with incarcerated abdominal wall hernia, or strangulated abdominal wall hernia; 9) The patient is judged by the clinician to have other factors that are not suitable for the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy rate (1-recurrence rate during 24 weeks after operation); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of surgical site infection;Degree of pain using VAS system;Other complications;AE/SAE;Device defect; | — |
Countries
China
Contacts
Public ContactJianxiong Tang
Huadong Hospital Affiliated To Fudan University
Outcome results
None listed