Trial Outcomes & Findings for Right Colon Polyp Miss Rates of Water Exchange and Carbon Dioxide Insufflation Colonoscopy (NCT NCT03845933)

Results Overview

Lesions detected on the tandem (second) right colon examination are used for the calculation of adenoma and hyperplastic polyp miss rate. Right colon adenoma miss rate (AMR) and right colon hyperplastic polyp miss rate (HPMR) are calculated as the number of adenomas and hyperplastic polyps detected during the second right colon examination divided by the total number of adenoma and hyperplastic polyps detected during both the first and second right colon examinations.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

262 participants

Primary outcome timeframe

One day

Results posted on

2019-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	Water Exchange (WE) Colonoscopy Water exchange will be used during colonoscopy insertion. Upon arriving at the cecum, CO2 will be opened. The scope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). The scope will be reinserted into the cecum by the first endoscopist. A tandem inspection of right colon will be performed by a second endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist. Colon polypectomy: Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed. All proximal colon polyps will be removed irrespective of their size and appearance.	CO2 Insufflation Colonoscopy The colonoscopy is performed in the usual fashion, with minimal insufflation required to aid insertion. Cleaning will be performed entirely during withdrawal. Upon arriving at the cecum, CO2 insufflation will be used and the scope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). Then the scope will be reinserted into the cecum by the first endoscopist using CO2. A tandem inspection of the right colon will then be performed by a second endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the mark of distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist. Colon polypectomy: Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed. All proximal colon polyps will be removed irrespective of their size and appearance.
Overall Study STARTED	131	131
Overall Study COMPLETED	131	131
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Water Exchange (WE) Colonoscopy n=131 Participants Water exchange will be used during colonoscopy insertion. Upon arriving at the cecum, CO2 will be opened. The scope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). The scope will be reinserted into the cecum by the first endoscopist. A tandem inspection of right colon will be performed by a second endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist. Colon polypectomy: Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed. All proximal colon polyps will be removed irrespective of their size and appearance.	CO2 Insufflation Colonoscopy n=131 Participants The colonoscopy is performed in the usual fashion, with minimal insufflation required to aid insertion. Cleaning will be performed entirely during withdrawal. Upon arriving at the cecum, CO2 insufflation will be used and the scope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). Then the scope will be reinserted into the cecum by the first endoscopist using CO2. A tandem inspection of the right colon will then be performed by a second endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the mark of distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist. Colon polypectomy: Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed. All proximal colon polyps will be removed irrespective of their size and appearance.	Total n=262 Participants Total of all reporting groups
Age, Continuous	56.7 years STANDARD_DEVIATION 8.8 • n=131 Participants	57.3 years STANDARD_DEVIATION 8.3 • n=131 Participants	57.0 years STANDARD_DEVIATION 8.5 • n=262 Participants
Sex: Female, Male Female	70 Participants n=131 Participants	64 Participants n=131 Participants	134 Participants n=262 Participants
Sex: Female, Male Male	61 Participants n=131 Participants	67 Participants n=131 Participants	128 Participants n=262 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Taiwan	131 participants n=131 Participants	131 participants n=131 Participants	262 participants n=262 Participants

PRIMARY outcome

Timeframe: One day

Lesions detected on the tandem (second) right colon examination are used for the calculation of adenoma and hyperplastic polyp miss rate. Right colon adenoma miss rate (AMR) and right colon hyperplastic polyp miss rate (HPMR) are calculated as the number of adenomas and hyperplastic polyps detected during the second right colon examination divided by the total number of adenoma and hyperplastic polyps detected during both the first and second right colon examinations.

Outcome measures

Outcome measures
Measure	Water Exchange (WE) Colonoscopy n=131 Participants Water exchange will be used during colonoscopy insertion. Upon arriving at the cecum, CO2 will be opened. The scope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). The scope will be reinserted into the cecum by the first endoscopist. A tandem inspection of right colon will be performed by a second endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist. Colon polypectomy: Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed. All proximal colon polyps will be removed irrespective of their size and appearance.	CO2 Insufflation Colonoscopy n=131 Participants The colonoscopy is performed in the usual fashion, with minimal insufflation required to aid insertion. Cleaning will be performed entirely during withdrawal. Upon arriving at the cecum, CO2 insufflation will be used and the scope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). Then the scope will be reinserted into the cecum by the first endoscopist using CO2. A tandem inspection of the right colon will then be performed by a second endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the mark of distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist. Colon polypectomy: Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed. All proximal colon polyps will be removed irrespective of their size and appearance.
Percentage of Adenomas and Hyperplastic Polyps Missed During Initial Right Colon Examination	18.0 percentage of all missed polyps Interval 13.9 to 23.2	36.7 percentage of all missed polyps Interval 30.0 to 44.8

Adverse Events

Water Exchange (WE) 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

Phone: 0919768058

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place