Adenoma Miss Rate With Water Exchange vs Carbon Dioxide Colonoscopy

Water Exchange Colonoscopy Decreased Adenoma Miss Rates in the Right and Proximal Colon: An Observational Study Using A Tandem Colonoscopy Approach

This was an observational study comparing consecutive group of WE and CO2 insufflation in terms of right and proximal colon AMR by tandem colonoscopy.

Study Overview

• Status: Completed
• Conditions: Colonic Adenoma; Water Exchange Colonoscopy
• Intervention / Treatment: Procedure: Water exchange colonoscopy; Procedure: CO2 insufflation colonoscopy

Detailed Description

This was a prospective observational study to assess how WE colonoscopy would fit into clinical and research practices. We first observed whether optimal WE colonoscopy decreased the AMR in the right and proximal colon in a tandem approach. If WE did lower the AMR as compared with data in the literature, a randomized RCT deserves to be studied. For the calculation of sample size in the upcoming RCT, the AMR in the CO2 group would be collected. The differences of the AMRs in the right and proximal colon determined by tandem colonoscopy using WE or CO2 insufflation would then be compared.

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 320
    • Evergreen General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

86 eligible patients completed first-pass colonoscopy with WE insertion and CO2 withdrawal, followed by back-to-back second-pass colonoscopy with CO2 insertion and CO2 withdrawal during July 9 to Oct 12, 2018; Another 86 eligible patient completed first-pass colonoscopy with CO2 insertion and CO2 withdrawal, followed by back-to-back second-pass colonoscopy with CO2 insertion and CO2 withdrawal during Oct 15 to Nov 21, 2018.

Description

Inclusion Criteria:

• Consecutive patients aged 20 years or older undergoing colonoscopy for screening and surveillance indications were considered for enrollment.

Exclusion Criteria:

• familial adenomatous polyposis and hereditary non-polyposis CRC syndrome, personal history of inflammatory bowel disease, previous colonic resection, inability to achieve cecal intubation, obstructive lesions of the colon, poor colon preparation, inability to completely remove a polyp, gastrointestinal bleeding, allergy to fentanyl or midazolam, American Society of Anesthesiology classification of physical status grade 3 or higher, mental retardation, pregnancy, and refusal to provide a written informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Water exchange colonoscopy; During the insertion phase of the first-pass colonoscopy, water exchange (WE) method was used. WE entailed the infusion of water to open the lumen and sequentially suction of water. When the cecum was reached and after most of the water was suctioned to collapse the cecal lumen, CO2 was opened during the withdrawal phase of the first-pass colonoscopy. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations.	Procedure: Water exchange colonoscopy; During back-to-back colonoscopy, the first examination was completed with water exchange during insertion and CO2 insufflation during withdrawal. The second examination was completed with CO2 insufflation during both the insertion and withdrawal.; Procedure: CO2 insufflation colonoscopy; During back-to-back colonoscopy, the first examination was completed with CO2 insufflation during both the insertion and withdrawal. The second examination was also completed with CO2 insufflation during both the insertion and withdrawal.
CO2 insufflation colonoscopy; During the first-pass colonoscopy, the procedure was performed in the usual fashion, with minimal CO2 insufflation to aid insertion. Cleaning of colon was predominantly performed during withdrawal. After the first complete withdrawal of the colonoscope, a second colonoscopic examination aided by CO2 insufflation during insertion and withdrawal was performed by the same endoscopist. The colonoscope was reinserted into the cecum as quickly as possible, and the entire colon was re-examined. Polyp resection was carried out during insertion and withdrawal of the first- and second-pass examinations.	Procedure: CO2 insufflation colonoscopy; During back-to-back colonoscopy, the first examination was completed with CO2 insufflation during both the insertion and withdrawal. The second examination was also completed with CO2 insufflation during both the insertion and withdrawal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Overall Detected Adenomas Missed During the First Right-Colon Colonoscopy	Right-colon (cecum, A-colon, hepatic flexure) adenomas detected on the second-pass examination were used for the calculation of adenoma miss. Adenoma miss rate was calculated as the number of adenomas missed in the first colonoscopy divided by the total number of adenomas detected during both the first and second colonoscopies.	During procedure, approximately 1.5 hours
Percentage of Overall Detected Adenomas Missed During the First Proximal-Colon Colonoscopy	Proximal-colon (cecum, A-colon, hepatic flexure, T-colon) adenomas detected on the second-pass examination were used for the calculation of adenoma miss. Adenoma miss rate was calculated as the number of adenomas missed in the first colonoscopy divided by the total number of adenomas detected during both the first and second colonoscopies.	During procedure, approximately 1.5 hours

Collaborators and Investigators

• Sponsor: Evergreen General Hospital, Taiwan

Publications and helpful links

General Publications

• Cheng CL, Kuo YL, Hsieh YH, Tang JH, Leung FW. Water exchange colonoscopy decreased adenoma miss rates compared with literature data and local data with CO2 insufflation: an observational study. BMC Gastroenterol. 2019 Aug 14;19(1):143. doi: 10.1186/s12876-019-1065-2.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): November 28, 2018
• Study Completion (Actual): November 28, 2018

Study Registration Dates

• First Submitted: February 2, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Adenoma detection rate; Adenoma miss rate
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: EGH-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No