Comparison of Procedural Sequences in Same-day Painless Bidirectional Endoscopy With Colonoscopic Water Exchange Method

NCT ID: NCT03638713

Last Updated: 2022-03-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2021-02-28

Brief Summary

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This prospective randomized controlled trial is to compare evaluate the optimal procedure sequence among patients undergoing water exchange colonoscopy.

Detailed Description

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Same-day esophagogastroduodenoscopy (EGD) and colonoscopy (bidirectional endoscopy; BDE) are commonly performed to evaluate for gastrointestinal conditions, such as active gastrointestinal bleeding, iron deficiency anemia, positive fecal occult blood tests and abdominal pain. EGD-colonoscopy sequence seems to be the reasonable choice for BDE using air or CO2. With the use of water exchange method, endoscopists have to remove the dirty fecal material and air bubble during insertion. Gas insufflated during EGD may get into the colon and make subsequent water exchange colonoscopy more difficult. The aim of this prospective randomized controlled trial is to compare evaluate the optimal procedure sequence among patients undergoing water exchange colonoscopy.

Conditions

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Colon Disease Bidirectional Endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A total of 200 patients were allocated into one of two groups by computerized randomization. Patients in the group A (colonoscopy first group) received colonoscopy followed by EGD and those in the group B (EGD first group) received EGD followed by colonoscopy.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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colonoscopy first group

Patients received water-exchange colonoscopy first and followed by esophagogastroduodenoscopy

Group Type EXPERIMENTAL

colonoscopy first

Intervention Type BEHAVIORAL

Received water exchange colonoscopy followed by EGD

EGD first group

Patients received esophagogastroduodenoscopy first and followed by water-exchange colonoscopy

Group Type ACTIVE_COMPARATOR

EGD first

Intervention Type BEHAVIORAL

Received EGD followed by water exchange colonoscopy

Interventions

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colonoscopy first

Received water exchange colonoscopy followed by EGD

Intervention Type BEHAVIORAL

EGD first

Received EGD followed by water exchange colonoscopy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients underwent fully sedated bidirectional endoscopy in the physical check-up department

Exclusion Criteria

* Patients who \< 18 years old, \> 80 years old
* Without standard colon preparation
* Allergy to meperidine or propofol
* With a history of partial colectomy
* Refusal to provide written informed consent
* American Society of Anesthesiology (ASA) risk Class 3 or higher
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dalin Tzu Chi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu-Hsi Hsieh, MD

Role: STUDY_DIRECTOR

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Locations

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Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Hsieh YH, Koo M, Tseng CW. Comparison of Procedural Sequences in Sedated Same-Day Bidirectional Endoscopy with Water-Exchange Colonoscopy: A Randomized Controlled Trial. J Clin Med. 2022 Mar 2;11(5):1365. doi: 10.3390/jcm11051365.

Reference Type DERIVED
PMID: 35268456 (View on PubMed)

Other Identifiers

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A10604001

Identifier Type: -

Identifier Source: org_study_id

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