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NCT03638713 Clinical Trial

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

Colon Disease Clinical Trial

Official title:
Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03638713
Other study ID # A10604001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date February 28, 2021

Study information
Verified date March 2022
Source Dalin Tzu Chi General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date February 28, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• colonoscopy first
Received water exchange colonoscopy followed by EGD
• EGD first
Received EGD followed by water exchange colonoscopy

Locations
Country Name City State
Taiwan Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation Taipei

Sponsors (1)
Lead Sponsor Collaborator
Dalin Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary cecal insertion time Cecal insertion time was defined as the time from insertion into the rectum to the time when the colonoscope tip passed to a point proximal to the ileocecal valve so that the base of cecum was visible. 30 minutes
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