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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469142
Recruitment Status : Unknown
Verified June 2015 by Xiaonan Liu, Xijing Hospital of Digestive Diseases.
Recruitment status was:  Active, not recruiting
First Posted : June 11, 2015
Last Update Posted : June 11, 2015
Sponsor:
Information provided by (Responsible Party):
Xiaonan Liu, 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.

Condition or disease Intervention/treatment Phase
Incarcerated Inguinal Hernia Procedure: ADM tension-free hernia reparation Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions
Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: ADM tension-free hernia reparation
Use ADM to repair incarcerated inguinal hernia by tension-free
Procedure: ADM tension-free hernia reparation
Use ADM as opposed to nothing to repair incarcerated inguinal hernia

Placebo Comparator: traditional tension hernia reparation
Just repair incarcerated inguinal hernia by nothing in tension condition



Primary Outcome Measures :
  1. the recurrence rate after operation [ Time Frame: ten years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469142


Locations
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China, Shanxi
Xijing Hospital
Xi'an, Shanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
Investigators
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Study Chair: xiaonan liu, MD Xijing Hospital
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Responsible Party: Xiaonan Liu, Principal Investigator, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT02469142    
Other Study ID Numbers: ADM001
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal