Adenoma Miss Rate With Water Exchange vs Carbon Dioxide Colonoscopy

NCT03832322 | Completed Results

• 1 other identifier: EGH-2018
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colonic Adenoma; Water Exchange Colonoscopy

Keywords

Adenoma miss rate; Adenoma detection rate

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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; Procedure: CO2 insufflation colonoscopy

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

Interventions

Water exchange colonoscopy PROCEDURE

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.

Water exchange colonoscopy

CO2 insufflation colonoscopy PROCEDURE

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; Water exchange colonoscopy

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Evergreen General Hospital, Taiwan: lead

Study Sites (1)

Evergreen General Hospital

Taoyuan District, 320, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 31412789 DERIVED

Results Point of Contact

• Title: Dr. Chi-Liang Cheng
• Organization: Evergreen General Hospital, Taiwan

chiliang.cheng@gmail.com

0919768058

Study Officials

• Chi-Liang Cheng

  Evergreen General Hospital, Taoyuan, Taiwan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 2, 2019
• First Posted: February 6, 2019
• Study Start: July 9, 2018
• Primary Completion: November 28, 2018
• Study Completion: November 28, 2018
• Last Updated: April 12, 2023
• Results First Posted: May 10, 2019

Record last verified: 2023-04

Locations

TW (1)