search
Back to results

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
Dalin Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 2, 2018
Last Updated
March 24, 2022
Sponsor
Dalin Tzu Chi General Hospital
search

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

We'll reach out to this number within 24 hrs