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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Bidirectional Endoscopy
• Colon Disease
• Colonic Diseases

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