Clinical trial NCT03832322: Adenoma Miss Rate With Water Exchange vs Carbon Dioxide Colonoscopy
Official title: Water Exchange Colonoscopy Decreased Adenoma Miss Rates in the Right and Proximal Colon: An Observational Study Using A Tandem Colonoscopy Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Adenoma
Water Exchange Colonoscopy
Keywords: Adenoma miss rate
Adenoma detection rate
Lead sponsor: Evergreen General Hospital, Taiwan
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 176
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 86 eligible patients completed first-pass colonoscopy with WE insertion and CO2 withdrawal, followed by back-to-back second-pass colonoscopy with CO2 insertion and CO2 withdrawal during July 9 to Oct 12, 2018; Another 86 eligible patient completed first-pass colonoscopy with CO2 insertion and CO2 withdrawal, followed by back-to-back second-pass colonoscopy with CO2 insertion and CO2 withdrawal during Oct 15 to Nov 21, 2018.

Brief summary: This was an observational study comparing consecutive group of WE and CO2 insufflation in terms of right and proximal colon AMR by tandem colonoscopy.

Detailed description: This was a prospective observational study to assess how WE colonoscopy would fit into clinical and research practices. We first observed whether optimal WE colonoscopy decreased the AMR in the right and proximal colon in a tandem approach. If WE did lower the AMR as compared with data in the literature, a randomized RCT deserves to be studied. For the calculation of sample size in the upcoming RCT, the AMR in the CO2 group would be collected. The differences of the AMRs in the right and proximal colon determined by tandem colonoscopy using WE or CO2 insufflation would then be compared.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients aged 20 years or older undergoing colonoscopy for screening and surveillance indications were considered for enrollment.

Exclusion Criteria:

* familial adenomatous polyposis and hereditary non-polyposis CRC syndrome, personal history of inflammatory bowel disease, previous colonic resection, inability to achieve cecal intubation, obstructive lesions of the colon, poor colon preparation, inability to completely remove a polyp, gastrointestinal bleeding, allergy to fentanyl or midazolam, American Society of Anesthesiology classification of physical status grade 3 or higher, mental retardation, pregnancy, and refusal to provide a written informed consent.

Primary outcomes:
measure: Percentage of Overall Detected Adenomas Missed During the First Right-Colon Colonoscopy
timeFrame: During procedure, approximately 1.5 hours
measure: Percentage of Overall Detected Adenomas Missed During the First Proximal-Colon Colonoscopy
timeFrame: During procedure, approximately 1.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Evergreen General Hospital
Study officials:
affiliation: Evergreen General Hospital, Taoyuan, Taiwan
name: Chi-Liang Cheng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng CL, Kuo YL, Hsieh YH, Tang JH, Leung FW. Water exchange colonoscopy decreased adenoma miss rates compared with literature data and local data with CO2 insufflation: an observational study. BMC Gastroenterol. 2019 Aug 14;19(1):143. doi: 10.1186/s12876-019-1065-2.