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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

Tracking Information
First Submitted Date  ICMJE February 16, 2019
First Posted Date  ICMJE February 19, 2019
Results First Submitted Date  ICMJE November 26, 2019
Results First Posted Date  ICMJE December 13, 2019
Last Update Posted Date December 17, 2019
Actual Study Start Date  ICMJE April 1, 2019
Actual Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2019)
Percentage of Adenomas and Hyperplastic Polyps Missed During Initial Right Colon Examination [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2019)
Right Colon Combined Adenoma and Hyperplastic Miss Rate [ Time Frame: One day ]
Lesions detected on the tandem right colon examination will be used for the calculation of adenoma or polyp miss rate. Right colon adenoma miss rate (AMR) and hyperplastic polyp miss rate (HPMR) will be calculated as the number of adenomas and hyperplastic polyps missed in the first right colon examination divided by the total number of adenoma and hyperplastic polyps detected during both the first and tandem right colon examinations.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Right Colon Polyp Miss Rates of Water Exchange and Carbon Dioxide Insufflation Colonoscopy
Official Title  ICMJE Comparing Right Colon Adenoma and Hyperplastic Polyp Miss Rate in Colonoscopy Using Water Exchange and Carbon Dioxide Insufflation: A Prospective Randomized Controlled Trial
Brief Summary This will be a prospective randomized controlled trial comparing CO2 insufflation and WE in terms of right colon combined adenoma miss rate (AMR) and hyperplastic polyp miss rate (HPMR) by tandem inspection. It will be a single-site study conducted in Taiwan.
Detailed Description This will be a prospective RCT comparing CO2 insufflation and WE in terms of right colon combined AMR and HPMR by tandem inspection. It is originally designed as a multicenter study conducted in three community hospitals in Taiwan. Consecutive patients will be enrolled from April 2019 to October 2020. A written informed consent will be obtained from all participating patients. The study has obtained ethical approval from the Joint Institutional Review Board of Taiwan (19-002-T-1) and has been registered with ClinicalTrials.gov (NCT03845933). Due to delay in obtaining IRB approval in two of the participating hospitals (Dalin Tzu-Chi Hospital obtained IRB approval in late May 2019 and has not recruited any patient; Taipei Medical University Hospital has not obtained IRB approval in early June 2019) and rapid recruitment of Evergreen General Hospital since April 2019, which has recruited and completed more than 90 patients in the end of May 2019, we have amended the study design from multicenter study to single-center study and have obtained the approval of this amendment from the Joint Institutional Review Board of Taiwan. Consecutive patients aged 45 years or older undergoing colonoscopy for screening, surveillance, and positive FIT will be considered for enrollment from April 2019 to October 2020. Participants will be randomized in a 1:1 ratio to undergo either the CO2 insufflation colonoscopy (CO2 group) or WE colonoscopy (WE group). Colonoscopies will be performed by two board-certified colonoscopists (Chi-Liang Cheng, Yen-Lin Kuo). Standard colonoscopes (CF-Q260AL/I; Olympus Medical Systems Corp., Tokyo, Japan) will be used. All colonoscopists have performed more than 1000 conventional colonoscopies. Hands-on coaching by a WE expert (Felix W. Leung) to standardize the WE method has been completed. Each colonoscopist has completed 100 cases of WE learning curve. Felix W. Leung will be involved in the study design, data analyses, and report preparation, but not in patient enrollment. CO2 insufflation will be used for CO2 group and the withdrawal phase of the WE group. In the WE group, the air pump will be turned off before starting the procedure. During the insertion phase, air and residual water or feces in the rectum will be aspirated, and then the colon will be irrigated with warm water. When the cecum is reached, CO2 will be opened. In the CO2 group, colonoscopy is performed in the usual fashion, with minimal insufflation required to aid insertion. Cleaning in the CO2 group will be performed entirely during withdrawal. Upon arriving at the cecum, CO2 insufflation will be used in both groups and the scope will be withdrawn from the cecum to the hepatic flexure, with inspection of the mucosa at the same time. All polyps identified will be resected and sent for pathology evaluation. The most distal part of the hepatic flexure will be marked by a forceps biopsy and then the scope will be reinserted into the cecum by the first endoscopist using CO2 insufflation. A tandem inspection of the right colon will then be performed by a second endoscopist blinded to the insertion method in both study groups. 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. Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
The second endoscopist will perform tandem right colon examination and is blinded to the insertion method used by the first endoscopist.
Primary Purpose: Treatment
Condition  ICMJE
  • Right Colon Adenoma Miss Rate
  • Right Colon Hyperplastic Polyp Miss Rate
Intervention  ICMJE Procedure: 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.
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Procedure: Colon polypectomy
  • Active Comparator: 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.
    Intervention: Procedure: Colon polypectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2019)
262
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2019)
468
Actual Study Completion Date  ICMJE October 31, 2019
Actual Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Consecutive patients aged 45 years or older undergoing colonoscopy for screening, surveillance, and positive FIT will be considered for enrollment.

Exclusion Criteria:

  • familial adenomatous polyposis and hereditary non-polyposis CRC syndrome, personal history of CRC or inflammatory bowel disease, previous colonic resection, obstructive lesions of the colon, gastrointestinal bleeding, allergy to fentanyl, midazolam or propofol, American Society of Anesthesiology (ASA) classification of physical status grade 3 or higher, mental retardation, pregnancy, and refusal to provide a written informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03845933
Other Study ID Numbers  ICMJE EGH-2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chi-Liang Cheng, Evergreen General Hospital, Taiwan
Study Sponsor  ICMJE Evergreen General Hospital, Taiwan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chiliang Cheng, MD Evergreen General Hospital
PRS Account Evergreen General Hospital, Taiwan
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP