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Adenoma Miss Rate With Water Exchange vs Carbon Dioxide Colonoscopy

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ClinicalTrials.gov Identifier: NCT03832322
Recruitment Status : Completed
First Posted : February 6, 2019
Results First Posted : May 10, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Chi-Liang Cheng, Evergreen General Hospital, Taiwan

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Colonic Adenoma
Water Exchange Colonoscopy
Interventions Procedure: Water exchange colonoscopy
Procedure: CO2 insufflation colonoscopy
Enrollment 176
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Water Exchange Colonoscopy CO2 Insufflation Colonoscopy
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 89 87
Completed 86 86
Not Completed 3 1
Reason Not Completed
Failed cecal intubation in 2nd exam             3             1
Arm/Group Title Water Exchange Colonoscopy CO2 Insufflation Colonoscopy Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 86 86 172
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 86 participants 172 participants
53.4  (10.7) 52.9  (9.6) 53.1  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 172 participants
Female
43
  50.0%
39
  45.3%
82
  47.7%
Male
43
  50.0%
47
  54.7%
90
  52.3%
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 86 participants 86 participants 172 participants
86 86 172
1.Primary Outcome
Title Percentage of Overall Detected Adenomas Missed During the First Right-Colon Colonoscopy
Hide Description 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.
Time Frame During procedure, approximately 1.5 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CO2 Insufflation Colonoscopy Water Exchange Colonoscopy
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 86 86
Mean (95% Confidence Interval)
Unit of Measure: percentage of detected adenomas
33.8
(23.2 to 45.7)
17.5
(9.1 to 29.1)
2.Primary Outcome
Title Percentage of Overall Detected Adenomas Missed During the First Proximal-Colon Colonoscopy
Hide Description 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.
Time Frame During procedure, approximately 1.5 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Water Exchange Colonoscopy CO2 Insufflation Colonoscopy
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 86 86
Mean (95% Confidence Interval)
Unit of Measure: percentage of detected adenomas
15.5
(8.5 to 25.0)
30.4
(22.0 to 39.8)
Time Frame one month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Water Exchange Colonoscopy CO2 Insufflation Colonoscopy
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Water Exchange Colonoscopy CO2 Insufflation Colonoscopy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/86 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Water Exchange Colonoscopy CO2 Insufflation Colonoscopy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/86 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Water Exchange Colonoscopy CO2 Insufflation Colonoscopy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/86 (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, Taiwan
Phone: 0919768058
EMail: chiliang.cheng@gmail.com
Layout table for additonal information
Responsible Party: Chi-Liang Cheng, Evergreen General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03832322     History of Changes
Other Study ID Numbers: EGH-2018
First Submitted: February 2, 2019
First Posted: February 6, 2019
Results First Submitted: February 8, 2019
Results First Posted: May 10, 2019
Last Update Posted: May 21, 2019