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Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions

Phase 2
Conditions
Incarcerated Inguinal Hernia
Interventions
Procedure: ADM tension-free hernia reparation
Registration Number
NCT02469142
Lead Sponsor
Xijing Hospital of Digestive Diseases
Brief Summary

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.

Detailed 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

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ADM tension-free hernia reparationADM tension-free hernia reparationUse ADM to repair incarcerated inguinal hernia by tension-free
Primary Outcome Measures
NameTimeMethod
the recurrence rate after operationten years
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Xijing Hospital

🇨🇳

Xi'an, Shanxi, China

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