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Right Colon Polyp Miss Rates of Water Exchange and Carbon Dioxide Insufflation Colonoscopy

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ClinicalTrials.gov Identifier: NCT03845933
Recruitment Status : Completed
First Posted : February 19, 2019
Results First Posted : December 13, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Chi-Liang Cheng, Evergreen General Hospital, Taiwan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Right Colon Adenoma Miss Rate
Right Colon Hyperplastic Polyp Miss Rate
Intervention Procedure: Colon polypectomy
Enrollment 262
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Water Exchange (WE) Colonoscopy CO2 Insufflation Colonoscopy
Hide Arm/Group Description

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 The scope will be withdrawn to the hepatic flexure.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.

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 Upon arriving at the cecum, CO2 insufflation will be used and the scope will be withdrawn to the hepatic flexure.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.

Period Title: Overall Study
Started 131 131
Completed 131 131
Not Completed 0 0
Arm/Group Title Water Exchange (WE) Colonoscopy CO2 Insufflation Colonoscopy Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 131 131 262
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 131 participants 131 participants 262 participants
56.7  (8.8) 57.3  (8.3) 57.0  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 131 participants 262 participants
Female
70
  53.4%
64
  48.9%
134
  51.1%
Male
61
  46.6%
67
  51.1%
128
  48.9%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 131 participants 131 participants 262 participants
131 131 262
1.Primary Outcome
Title Percentage of Adenomas and Hyperplastic Polyps Missed During Initial Right Colon Examination
Hide Description 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.
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Water Exchange (WE) Colonoscopy CO2 Insufflation Colonoscopy
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 131 131
Mean (95% Confidence Interval)
Unit of Measure: percentage of all missed polyps
18.0
(13.9 to 23.2)
36.7
(30.0 to 44.8)
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Water Exchange (WE) Colonoscopy CO2 Insufflation Colonoscopy
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Water Exchange (WE) Colonoscopy CO2 Insufflation Colonoscopy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/131 (0.00%)   0/131 (0.00%) 
Hide Serious Adverse Events
Water Exchange (WE) Colonoscopy CO2 Insufflation Colonoscopy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/131 (0.00%)   0/131 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Water Exchange (WE) Colonoscopy CO2 Insufflation Colonoscopy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/131 (0.00%)   0/131 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Chi-Liang Cheng
Organization: Evergreen General Hospital
Phone: 0919768058
EMail: chiliang.cheng@gmail.com
Layout table for additonal information
Responsible Party: Chi-Liang Cheng, Evergreen General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03845933    
Other Study ID Numbers: EGH-2019
First Submitted: February 16, 2019
First Posted: February 19, 2019
Results First Submitted: November 26, 2019
Results First Posted: December 13, 2019
Last Update Posted: December 17, 2019