Video Consent Form Versus Written Consent Form for ERCP

NCT ID: NCT02810379

Last Updated: 2016-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Brief Summary

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To prove that video about endoscopic retrograde cholangiopancreatography (ERCP) combined with written informed consent provides participants more information about the procedure, which can make participants understand the procedure well. Investigators advocate the development of institutional and national guidelines to ensure optimal practices of acquiring informed consent.

Detailed Description

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Conditions

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Consent Forms of ERCP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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written informed consent

participants read the written informed consent documents befor ERCP

Group Type PLACEBO_COMPARATOR

written informed consent

Intervention Type PROCEDURE

video+written informed consent

participants watch a video about the ERCP and read the written informed consent documents before ERCP

Group Type EXPERIMENTAL

video+written informed consent

Intervention Type PROCEDURE

Interventions

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written informed consent

Intervention Type PROCEDURE

video+written informed consent

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All inpatients who will receive ERCP

Exclusion Criteria

* under 18 years or more than 70 years
* pregnancy or breast-feeding women
* circulatory and respiratory disorders
* mental illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Director of Gastroenterology Dept.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhaoshen Li, MD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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Changhai Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhaoshen Li, MD

Role: CONTACT

+86-21-25070552

Yu Bai, MD

Role: CONTACT

+86-13564665324

Facility Contacts

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Zhaoshen Li, MD

Role: primary

References

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Xia T, Zhu YB, Zeng YB, Chen C, Wang SL, Zhao SB, Su XJ, Wang D, Yao J, Li ZS, Bai Y. Video education can improve awareness of risks for patients undergoing endoscopic retrograde cholangiopancreatography: A randomized trial. J Dig Dis. 2019 Dec;20(12):656-662. doi: 10.1111/1751-2980.12824. Epub 2019 Nov 21.

Reference Type DERIVED
PMID: 31618520 (View on PubMed)

Other Identifiers

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ERCP-1

Identifier Type: -

Identifier Source: org_study_id

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