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

Incarcerated Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02469142
• Other study ID #: ADM001
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: January 4, 2015
• Last updated: June 8, 2015
• Start date: January 2015
• Est. completion date: December 2019

Study information

• Verified date: June 2015
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Incarcerated Inguinal Hernia

Intervention

Procedure:
• ADM tension-free hernia reparation
Use ADM as opposed to nothing to repair incarcerated inguinal hernia

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the recurrence rate after operation		ten years	Yes