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

June 8, 2015 updated by: Xiaonan Liu, Xijing Hospital of Digestive Diseases
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanxi
      • Xi'an, Shanxi, China, 710032
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 85 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the recurrence rate after operation
Time Frame: ten years
ten years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital of Digestive Diseases

Investigators

  • Study Chair: xiaonan liu, MD, Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

January 4, 2015

First Submitted That Met QC Criteria

June 8, 2015

First Posted (ESTIMATE)

June 11, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

June 11, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADM001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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