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

Primary Purpose

Incarcerated Inguinal Hernia

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ADM tension-free hernia reparation
Sponsored by
Xijing Hospital of Digestive Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incarcerated Inguinal Hernia

Eligibility Criteria

16 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ADM tension-free hernia reparation

traditional tension hernia reparation

Arm Description

Use ADM to repair incarcerated inguinal hernia by tension-free

Just repair incarcerated inguinal hernia by nothing in tension condition

Outcomes

Primary Outcome Measures

the recurrence rate after operation

Secondary Outcome Measures

Full Information

First Posted
January 4, 2015
Last Updated
June 8, 2015
Sponsor
Xijing Hospital of Digestive Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT02469142
Brief Title
Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions
Official Title
Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: recurrence rate after operation incidence rate of complications postoperative hospital stay hospitalization costs 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incarcerated Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADM tension-free hernia reparation
Arm Type
Experimental
Arm Description
Use ADM to repair incarcerated inguinal hernia by tension-free
Arm Title
traditional tension hernia reparation
Arm Type
Placebo Comparator
Arm Description
Just repair incarcerated inguinal hernia by nothing in tension condition
Intervention Type
Procedure
Intervention Name(s)
ADM tension-free hernia reparation
Intervention Description
Use ADM as opposed to nothing to repair incarcerated inguinal hernia
Primary Outcome Measure Information:
Title
the recurrence rate after operation
Time Frame
ten years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaonan liu, MD
Organizational Affiliation
Xijing Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

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

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