NCT02328248

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2014

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

November 28, 2014

Last Update Submit

December 26, 2014

Conditions

Hiatal Hernia

Outcome Measures

Primary Outcomes (1)

  • The incidence of complications in all case

    five years

Study Arms (2)

Biological patch

EXPERIMENTAL

Use biological patch (Biodesign Surgisis Tissue Graft from Cook Biotech Incorporated) to repair hiatal hernia laparoscopically

Procedure: Biological patch

Plastic patch

PLACEBO COMPARATOR

Use plastic patch (Parietex Composite from Sofradim Production) to repair hiatal hernia laparoscopically

Interventions

Biological patchPROCEDURE

Use biological patch as opposed to plastic patch to repair hiatal hernia laparoscopically

Biological patch

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Xiaonan Liu, Ph.D

    Xijing Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

November 28, 2014

First Posted

December 31, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

December 31, 2014

Record last verified: 2014-12