Evaluation of the Impact of Water Method During Insertion Phase of Flexible Sigmoidoscopy in Training
NCT03208283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2024-02-07
Summary
Colonoscopy is a sedated procedure traditionally performed using air insufflation during the insertion phase of the procedure. Recently, the use of water method (eg, water infusion or water exchange techniques) during the insertion phase of colonoscopy has been reported to increase the proportion of patients in whom complete unsedated colonoscopy could be achieved, reduce patient recovery time burdens, decrease abdominal discomfort during and after colonoscopy, enhance cecal intubation, and increase willingness to repeat an unsedated colonoscopy. However, there has been no study on the use of water method during the training of primary care doctors or nurse endoscopists in flexible sigmoidoscopy for colorectal cancer screening.
In unsedated endoscopic procedure such as FS, endoscope insertion techniques that can potentially reduce patient discomfort and increase the rate of achieving an adequate depth of scope insertion are desirable. Our current study aims to evaluate the impact of water method during insertion phase of FS in the training of primary care doctors or nurse endoscopists for colorectal cancer screening.
Conditions
- Colorectal Cancer Screening
Interventions
- DIAGNOSTIC_TEST
-
Water method group
During the insertion phase of the initial 30 FS procedures, sterile water will be infused by a standard endoscopy water pump into the distal colon to allow passage of endoscope to ≥ 50cm above anal verge (including rectum, sigmoid colon and part of descending colon), or to the limit of patient tolerance of an unsedated procedure. Air insufflation will not be used during the insertion phase. Trainees will be allowed 10 minutes for the insertion phase. The unassisted portion of the examination would be terminated if reasonable progress is not being attained, excessive patient discomfort observed, or the supervising endoscopist believes that patient safety may be compromised. During the withdrawal phase, air insufflation will be used in standard fashion for examination of the colonic mucosa.
- DIAGNOSTIC_TEST
-
Air insufflation group
During the insertion phase of the initial 30 FS procedures, air insufflation will be used to allow passage of endoscope to at least 50cm above anal verge (including rectum, sigmoid colon and part of descending colon), or to the limit of patient tolerance of an unsedated procedure. Trainees will be allowed 10 minutes for the insertion phase. The unassisted portion of the examination would be terminated if reasonable progress is not being attained, excessive patient discomfort observed, or the supervising endoscopist believes that patient safety may be compromised. During the withdrawal phase, air insufflation will be used in standard fashion for examination of the colonic mucosa.
Sponsors & Collaborators
-
Chinese University of Hong Kong
lead OTHER
Principal Investigators
-
Shing Yan Raymond Tang · Chinese University of Hong Kong
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-10-28
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
Countries
- Hong Kong
Study Locations
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