Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03208283 |
| Other study ID # |
FSW |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 28, 2014 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Chinese University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
It is estimated that there are about 1.2 million patients with colorectal cancer (CRC)
worldwide, with a rising trend in CRC incidence and mortality globally. In Hong Kong,
colorectal cancer ranks first in cancer incidence and second in cancer mortality.
CRC is one of the most preventable cancers because its development in general follows an
adenoma-carcinoma sequence. Adenomas are considered precursor lesions for CRC. Recent
guidelines from USA, Europe and Asia Pacific region recommend CRC screening for average-risk
asymptomatic individuals starting at age 50. Modalities such as guaiac-based fecal occult
blood tests (gFOBT), fecal immunochemical tests (FIT), flexible sigmoidoscopy, and
colonoscopy are among the acceptable options for CRC screening. Studies have shown that early
detection and removal of colorectal adenoma by screening flexible sigmoidoscopy (FS) and
screening colonoscopy with polypectomy reduce CRC incidence and mortality.
Approximately two-thirds of CRC are located in the sigmoid colon and rectum, which can be
diagnosed by FS. In countries where colonoscopy may not be widely available or a prolonged
waiting time exists, FS becomes an attractive option for CRC screening.
When compared to colonoscopy, FS has the advantages of being an unsedated procedure,
requiring less stringent bowel prep, and being less technically demanding. While flexible
sigmoidoscopy have traditionally been performed by gastroenterologists or surgeons, studies
have demonstrated that adequately trained primary care doctors and nurse endoscopists can
perform screening flexible sigmoidoscopy as safely and effectively as gastroenterologists or
surgeons. The American Society for Gastrointestinal Endoscopy (ASGE), the Society of American
Gastrointestinal Endoscopic Surgeons (SAGES), and the The Society of Gastrointestinal Nurses
and Associates (SGNA) recommend 25 supervised procedures for training in FS. Hawes R et al
reported that at least 30 supervised procedures were needed before 85% - 90% of the
procedures were graded as competent in doctors without prior experience on rigid
sigmoidoscopy. In another report, at least 50 supervised procedures have been suggested for
FS training of clinicians without prior endoscopic skills.
From a technical standpoint, 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.
