Comparison of Procedural Sequences in Same-day Painless Bidirectional Endoscopy With Colonoscopic Water Exchange Method
Primary Purpose
Colon Disease, Bidirectional Endoscopy
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
colonoscopy first
EGD first
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Disease focused on measuring water exchange, colonoscopy, cecal insertion time, bidirectional endoscopy
Eligibility Criteria
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
Sites / Locations
- Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
colonoscopy first group
EGD first group
Arm Description
Patients received water-exchange colonoscopy first and followed by esophagogastroduodenoscopy
Patients received esophagogastroduodenoscopy first and followed by water-exchange colonoscopy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03638713
First Posted
July 2, 2018
Last Updated
March 24, 2022
Sponsor
Dalin Tzu Chi General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03638713
Brief Title
Comparison of Procedural Sequences in Same-day Painless Bidirectional Endoscopy With Colonoscopic Water Exchange Method
Official Title
Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dalin Tzu Chi General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This prospective randomized controlled trial is to compare evaluate the optimal procedure sequence among patients undergoing water exchange colonoscopy.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Disease, Bidirectional Endoscopy
Keywords
water exchange, colonoscopy, cecal insertion time, bidirectional endoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
colonoscopy first group
Arm Type
Experimental
Arm Description
Patients received water-exchange colonoscopy first and followed by esophagogastroduodenoscopy
Arm Title
EGD first group
Arm Type
Active Comparator
Arm Description
Patients received esophagogastroduodenoscopy first and followed by water-exchange colonoscopy
Intervention Type
Behavioral
Intervention Name(s)
colonoscopy first
Intervention Description
Received water exchange colonoscopy followed by EGD
Intervention Type
Behavioral
Intervention Name(s)
EGD first
Intervention Description
Received EGD followed by water exchange colonoscopy
Primary Outcome Measure Information:
Title
cecal insertion time
Description
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.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Hsi Hsieh, MD
Organizational Affiliation
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
City
Taipei
ZIP/Postal Code
62247
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
35268456
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison of Procedural Sequences in Same-day Painless Bidirectional Endoscopy With Colonoscopic Water Exchange Method
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