Adenoma Miss Rate With Water Exchange vs Carbon Dioxide Colonoscopy

NCT03832322 — Completed, 176 participants, Evergreen General Hospital, Taiwan

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Water Exchange Colonoscopy Decreased Adenoma Miss Rates in the Right and Proximal Colon: An Observational Study Using A Tandem Colonoscopy Approach

RegistryNCT03832322
StatusCompleted
Study typeObservational
Enrollment176 (Actual)
SponsorEvergreen General Hospital, Taiwan (Other)
ConditionsColonic Adenoma, Water Exchange Colonoscopy
InterventionsWater exchange colonoscopy, CO2 insufflation colonoscopy (Procedure)
Datesstart 2018-07-09, primary completion 2018-11-28, completion 2018-11-28, first posted 2019-02-06, last updated 2023-04-12
Locations1 site in Taiwan

Related Papers Related Patents Related Grants Related Experts
All trials for Colonic Adenoma All trials for Water Exchange Colonoscopy All trials of Water exchange colonoscopy All trials of CO2 insufflation colonoscopy

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Water exchange colonoscopyProcedure: Water exchange colonoscopy; Procedure: CO2 insufflation colonoscopyDuring 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.
CO2 insufflation colonoscopyProcedure: CO2 insufflation colonoscopyDuring 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.
  • Water exchange colonoscopy (Procedure): During back-to-back colonoscopy, the first examination was completed with water exchange during insertion and CO2 insufflation during withdrawal. The second examination was completed with CO2 insufflation during both the insertion and withdrawal.
  • CO2 insufflation colonoscopy (Procedure): During back-to-back colonoscopy, the first examination was completed with CO2 insufflation during both the insertion and withdrawal. The second examination was also completed with CO2 insufflation during both the insertion and withdrawal.

+Outcome measures

Primary outcomes

  • Percentage of Overall Detected Adenomas Missed During the First Right-Colon Colonoscopy [During procedure, approximately 1.5 hours]: 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.
  • Percentage of Overall Detected Adenomas Missed During the First Proximal-Colon Colonoscopy [During procedure, approximately 1.5 hours]: 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.

+Eligibility

Sex: All, ages: 20 Years to 75 Years

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.

+Posted results

Participant flow

MilestoneWater Exchange ColonoscopyCO2 Insufflation Colonoscopy
Started8987
Completed8686
Not completed31

Outcome results

  • Percentage of Overall Detected Adenomas Missed During the First Right-Colon Colonoscopy (Primary), Mean, percentage of detected adenomas: CO2 Insufflation Colonoscopy 33.8 (23.2 to 45.7); Water Exchange Colonoscopy 17.5 (9.1 to 29.1)
  • Percentage of Overall Detected Adenomas Missed During the First Proximal-Colon Colonoscopy (Primary), Mean, percentage of detected adenomas: Water Exchange Colonoscopy 15.5 (8.5 to 25.0); CO2 Insufflation Colonoscopy 30.4 (22.0 to 39.8)

Adverse events

Time frame: one month

ArmDeathsSerious adverse eventsOther adverse events
Water Exchange Colonoscopy0/86 (0.0%)0/86 (0.0%)0/86 (0.0%)
CO2 Insufflation Colonoscopy0/86 (0.0%)0/86 (0.0%)0/86 (0.0%)

+Locations (1)

FacilityCityCountryStatus
Evergreen General HospitalTaoyuanTaiwan

+Publications

  • Results publication: 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. PMID 31412789

+Study documents

+Investigators

  • Chi-Liang Cheng, Principal investigator, Evergreen General Hospital, Taoyuan, Taiwan