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

NCT03638713 | Completed

• 1 other identifier: A10604001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colon Disease; Bidirectional Endoscopy

Keywords

water exchange; colonoscopy; cecal insertion time; bidirectional endoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

colonoscopy first group

EXPERIMENTAL

Patients received water-exchange colonoscopy first and followed by esophagogastroduodenoscopy

Behavioral: colonoscopy first

EGD first group

ACTIVE COMPARATOR

Patients received esophagogastroduodenoscopy first and followed by water-exchange colonoscopy

Behavioral: EGD first

Interventions

colonoscopy first BEHAVIORAL

Received water exchange colonoscopy followed by EGD

colonoscopy first group

EGD first BEHAVIORAL

Received EGD followed by water exchange colonoscopy

EGD first group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalin Tzu Chi General Hospital: lead

Study Sites (1)

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taipei, 62247, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 35268456 DERIVED

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Yu-Hsi Hsieh, MD

  Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 20, 2018
• Study Start: May 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: February 28, 2021
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

TW (1)