Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions
This trial is active, not recruiting.
|Condition||incarcerated inguinal hernia|
|Treatment||adm tension-free hernia reparation|
|Phase||phase 2/phase 3|
|Sponsor||Xijing Hospital of Digestive Diseases|
|Start date||January 2015|
|End date||December 2019|
|Trial size||100 participants|
|Trial identifier||NCT02469142, ADM001|
Incarcerated inguinal hernia is one of the common acute abdomen abdominal surgery, often prone to intestinal necrosis and acute peritonitis.Using traditional tension hernia reparation, the recurrence rate were as high as 30%. In recent years, biological materials especially acellular matrix materials (Acellular Dermal Matrix, ADM) in resisting the infection, has become a research hotspot. In the project, the investigators try to address the role of ADM in incarcerated inguinal hernia patients.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
the recurrence rate after operation
time frame: ten years
Male or female participants from 16 years up to 85 years old.
Inclusion Criteria: - Clinical diagnosis of incarcerated hernia - randomly select patch agreed by patients and family members Exclusion Criteria: - severe organ dysfunction - No-tolerate anesthesia - No-suitable for operation - glucocorticoid with long-term use - Sever intraperitoneal adhesion existed - spirit disease patients - automatically exit
|Official title||Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions|
|Description||observation indicator: 1. recurrence rate after operation 2. incidence rate of complications 3. postoperative hospital stay 4. hospitalization costs 5. Self-evaluation of gastroesophageal reflux symptoms and quality of life(QOL) in 6th-month, 1st-year,2nd-year,3rd-year,4th-year and 5th-year after operation|
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