Evaluation of the Impact of Water Method During Insertion Phase of Flexible Sigmoidoscopy in Training

NCT03208283 | Completed DMC

• 1 other identifier: FSW
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Independently performed flexible sigmoidoscopy completion rate by each trainee

  The percentage of unassisted FS procedure completed within the allowed 10 minutes in the initial 30 FS procedures for each trainee endoscopist

  12 weeks

• The mean independently performed flexible sigmoidoscopy completion rate in each study group

  2\) The mean percentage of unassisted FS procedure completed within the allowed 10 minutes in the initial 30 FS procedures by all trainee endoscopists in the air insufflation group, and the water method group, respectively

  12 weeks

Secondary Outcomes (4)

• Polyp detection rate

  12 weeks

• Insertion distance

  12 weeks

• Procedural time

  12 weeks

• Patients' satisfaction

  12 weeks

Study Arms (2)

Air insufflation group

ACTIVE COMPARATOR

During the insertion phase of the initial 30 FS procedures, air insufflation will be used 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. 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

Water method group

ACTIVE COMPARATOR

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: Water method group

Interventions

Water method group DIAGNOSTIC_TEST

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.

Also known as: Water Immersion

Water method group

Air insufflation group DIAGNOSTIC_TEST

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.

Also known as: Air insufflation

Air insufflation group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive asymptomatic patients suitable for CRC screening by FS
• Age 50 - 70 years
• Written informed consent available

You may not qualify if:

• Contraindications for endoscopy due to comorbidities
• Unable to provide written informed consent
• Personal history of polyposis syndrome, personal history of CRC, personal history of inflammatory bowel disease
• Coagulopathy (INR\>1.5) or thrombocytopenia (platelets \<50,000)
• Pregnant patients

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Centre for Digestive Health, Institute of Digestive Disease, Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Pneumoradiography

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Shing Yan Raymond Tang

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of S.H. Ho Centre for Digestive Health, Institute of Digestive Disease, the Chinese University of Hong Kong

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: July 5, 2017
• Study Start: October 28, 2014
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)