Inguinal hernia
Conditions
Interventions
Test group of open surgery queue:The standard tension-free herniorrhaphy (Lichtenstei) procedure was performed using the zhuoruan biological herniorrhaphy mesh
Control group of open surgery queue:COOK's baide plug herniorrhaphy mesh was used to perform standard tension-free herniorrhaphy (Lichtenstei)
Test group of laparoscopic surgery queue:Laparoscopic hernia repair using Zhuoruan biological hernia patch
Control group of laparoscopic surgery queue:Laparoscopic hernia repair using Ultrapro mesh
Sponsors
Huadong Hospital?Ruijin Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 85 years male or female; 2. Unilateral primary inguinal hernia while open surgery for Gilbert parting I~ V and laparoscopic surgery in Gilbert points I~ VII; 3. Herniorrhaphy is required without absolute contraindications; 4. Patients voluntarily participate in clinical trials and sign informed consent forms, which can cooperate with clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with bilateral inguinal hernia, incarcerated hernia/strangulated hernia, recurrent hernia or intestinal obstruction; 2. Unable to accept pig-derived equipment due to religious or ethnic issues; 3. Participated in clinical trials of other drugs or medical devices in the last 6 months; 4. Patients with acute infection or those with poor control of focal infection have skin diseases around the incision; 5. Severe heart, liver and kidney insufficiency is defined as: (1) cardiac function: level III and above; (2) 2.5 times the normal upper limit of ALT or AST; (3) 2.5 times the normal upper limit of serum creatinine. 6. The presence of serious diseases (such as severe prostatic hyperplasia, constipation, asthma or chronic cough) causing increased abdominal pressure; Uncontrollable ascites caused by cirrhosis of the liver or tumor, etc.); 7. Poor control of diabetic patients (fasting blood glucose > 11.1mmol/L); 8. Patients with various malignant tumors and chronic wasting diseases that cause dysplasm and cannot tolerate surgery; Life expectancy less than 6 months; 10. Specific allergy constitution; 11. Obvious abnormal coagulation function (prothrombin time extended > for 6 seconds); 12. Pregnant or planned pregnant women and lactating women; 13. Mentally abnormal without the ability to act autonomously; 14. Other circumstances in which doctors judge that they cannot participate in the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| None-recurrence rate of hernia 180 days after operation; | — |
Countries
China
Contacts
Public ContactYanyan Wang
Zhuo Ruan Medical Technology (Suzhou) Co., Ltd.
Outcome results
None listed