Usage of Biological Patch Versus Plastic in the Laparoscopic Repair of Hiatal Hernias

December 26, 2014 updated by: Xiaonan Liu, Xijing Hospital of Digestive Diseases

Randomized Control Trial (RCT) That the Usage With Biological Patch Versus Plastic in the Laparoscopic Repair

The purpose of this study is to observe the effective and safety in the laparoscopic repair of hiatal hernia using biological patch versus plastic.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

observation indicator:

  1. incidence rate of complications,
  2. postoperative hospital stay
  3. readmission rate in 1st month after operation
  4. recurrence rate after operation
  5. hospitalization costs
  6. 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)

150

Phase

  • Phase 2
  • Phase 3

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Hiatal hernia
  • Consistent with operation indications throughout the guideline of hiatal hernia by the Chinese Medical Association in 2003
  • randomly select patch agreed by patients and family members

Exclusion Criteria:

  • Poor general condition
  • severe organ dysfunction
  • No-tolerate anesthesia
  • No-suitable for operation
  • Emergency operation needed
  • Serious adverse events appeared during the operation
  • Sever intraperitoneal adhesion existed
  • glucocorticoid with long-term use
  • immunocompromised patients
  • spirit disease patients
  • automatically exit
  • women who pregnant

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: Biological patch
Use biological patch (Biodesign Surgisis Tissue Graft from Cook Biotech Incorporated) to repair hiatal hernia laparoscopically
Procedure: Biological patch
Use biological patch as opposed to plastic patch to repair hiatal hernia laparoscopically
PLACEBO_COMPARATOR: Plastic patch
Use plastic patch (Parietex Composite from Sofradim Production) to repair hiatal hernia laparoscopically

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of complications in all case
Time Frame: five years
five years

Collaborators and Investigators

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

Sponsor

Xijing Hospital of Digestive Diseases

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

July 1, 2014

Primary Completion (ANTICIPATED)

July 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

November 28, 2014

First Submitted That Met QC Criteria

December 26, 2014

First Posted (ESTIMATE)

December 31, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 26, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HH-001

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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