Trial Outcomes & Findings for Adenoma Miss Rate With Water Exchange vs Carbon Dioxide Colonoscopy (NCT NCT03832322)

NCT ID: NCT03832322

Last Updated: 2023-04-12

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 176 participants
• Primary outcome timeframe: During procedure, approximately 1.5 hours
• Results posted on: 2023-04-12

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	89	87
Overall Study COMPLETED	86	86
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	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.	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.
Overall Study Failed cecal intubation in 2nd exam	3	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Water Exchange Colonoscopy n=86 Participants During the insertion phase of the first-pass colonoscopy, WE method was used. When the cecum was reached, 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.	CO2 Insufflation Colonoscopy n=86 Participants 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.	Total n=172 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 10.7 • n=86 Participants	52.9 years STANDARD_DEVIATION 9.6 • n=86 Participants	53.1 years STANDARD_DEVIATION 10.1 • n=172 Participants
Sex: Female, Male Female	43 Participants n=86 Participants	39 Participants n=86 Participants	82 Participants n=172 Participants
Sex: Female, Male Male	43 Participants n=86 Participants	47 Participants n=86 Participants	90 Participants n=172 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Taiwan	86 participants n=86 Participants	86 participants n=86 Participants	172 participants n=172 Participants

PRIMARY outcome

Timeframe: During procedure, approximately 1.5 hours

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.

Outcome measures

Measure	CO2 Insufflation Colonoscopy n=86 Participants 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.	Water Exchange Colonoscopy n=86 Participants 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.
Percentage of Overall Detected Adenomas Missed During the First Right-Colon Colonoscopy	33.8 percentage of detected adenomas Interval 23.2 to 45.7	17.5 percentage of detected adenomas Interval 9.1 to 29.1

PRIMARY outcome

Timeframe: During procedure, approximately 1.5 hours

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.

Outcome measures

Measure	CO2 Insufflation Colonoscopy n=86 Participants 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.	Water Exchange Colonoscopy n=86 Participants 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.
Percentage of Overall Detected Adenomas Missed During the First Proximal-Colon Colonoscopy	15.5 percentage of detected adenomas Interval 8.5 to 25.0	30.4 percentage of detected adenomas Interval 22.0 to 39.8

Adverse Events

Water Exchange Colonoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CO2 Insufflation Colonoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Chi-Liang Cheng

Evergreen General Hospital, Taiwan

Phone: 0919768058

Email: chiliang.cheng@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place