Investigation of Cecal Intubation Rates and Pain Levels Between Water Exchange and Air Insufflation Flexible Sigmoidoscopy

Colorectal Cancer Clinical Trial

Official title:

Investigation of Cecal Intubation Rates and Pain Levels Between Water Exchange and Air Insufflation Flexible Sigmoidoscopy: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209349
• Other study ID #: 2016-17-078-I
• Status: Completed
• Phase: N/A
• Start date: June 14, 2017
• Est. completion date: November 3, 2022

Study information

• Verified date: November 2022
• Source: Kelowna Gastroenterology Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates how often patients without sedation that receive screening sigmoidoscopy are able to have their full colon examined without significant discomfort by comparing a new colonoscopy technique known as the water exchange technique to the traditional air insufflation technique. It compares the differences between complete colon exam rates for water exchange when compared to the traditional air technique. Patients will be randomised and blinded to the procedure type.

Previous studies have shown that the water exchange method is associated with a significant reduction in discomfort and often allows patients to receive colonoscopy without sedation or with only minimal sedation. However, the potential for water exchange to be used in the screening setting has yet to be evaluated. As per standard practices in sigmoidoscopy screening, patients will not be sedated. However, unlike standard practices in sigmoidoscopy screening, while maintaining minimal levels of discomfort, the investigators will attempt to scope beyond the distal colon.

Description:

Purpose:

This study is being conducted to evaluate whether a new technique, known as the water exchange technique can more frequently allow for the full colon to be examined in patients undergoing screening sigmoidoscopy.*

Hypothesis & Goals & Objectives:

It is hypothesised that there will be a 20% or greater difference in cecal intubation rate (ability for the colonoscope to reach the Ileocecal juncture, and thereby provide full examination of the colon) at a minimal and acceptable level of discomfort in non-sedated colon screening patients receiving a scope using the water-exchange method, when compared to the air insufflation method.

Justification:

Previous studies have shown that the water exchange method is associated with a significant reduction in discomfort and often allows patients to receive colonoscopy without sedation or with only minimal sedation. The ability to increase the likelihood of full colon examination at minimal discomfort has the opportunity to improve upon screening practices and increase the likelihood of patient participation as discomfort and fear of discomfort is a major factor that limits uptake of sigmoidoscopy and colonoscopy screening.

Research Design:

This study takes a patient and interviewer blinded and randomised study design. Patients will be randomly assigned to receive either the water exchange method or the air insufflation method. Rates of cecal intubation are compared across study arms.

Statistical Analysis Plan:

Effect differences in cecal intubation rates, and responses to whether the scope that they received was more uncomfortable than they expected, and whether they would be willing to receive the test again at their next screening interval will be compared using the Chi-Squared or, when the data necessitates, Fisher's Exact Test. Assuming a non-normal distribution in reported pain scores, the Mann Whitney U test will be used to assess the differences in maximum reported pain according to the Wong Baker Faces Pain Rating Scale between study arms.

*The term sigmoidoscopy is used here as patients are prepared for the procedure using a standard sigmoidoscopy protocol, rather than colonoscopy. That is, sedation is not administered; this is a standard practice for sigmoidoscopy procedures but not for colonoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 3, 2022
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

Inclusion Criteria:

• Asymptomatic average risk (as per BC colon screening guidelines) individuals

• Ages 50-74 years of age

Exclusion Criteria:

• A sigmoidoscopy or colonoscopy within 10 years,

• A FIT within 2 years,

• Individuals classified with any high-risk screening criteria in accordance to the

BC colon screening guidelines including:

• a personal history of adenoma,

• a first degree relative that was diagnosed with colorectal cancer or multiple adenomas under the age of 60,

• two or more first degree relatives with colorectal cancer at any age, longstanding inflammatory bowel diseases,

• a family history of familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer, - Individuals presenting with rectal pain, rectal bleeding, abdominal pain, or unintentional weight loss at the time of the examination.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Water Exchange Sigmoidoscopy
See arm description.
• Air Insufflation Sigmoidoscopy
See arm description.

Locations

Country	Name	City	State
Canada	Brent Parker	Kelowna	British Columbia
United States	Sepulveda Ambulatory Care Center	North Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
Kelowna Gastroenterology Associates	Veteran Affairs Sepulveda Ambulatory Care Cente

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Full colon exam	Ability for patient to receive full exam of the colon with minimal discomfort	Immediately following the procedure
Secondary	Recalled Discomfort	Patient will be contacted at 24 hours following the procedure and in order to document whether the scope was more uncomfortable than expected and if the patient would be willing to receive the test again at their next screening interval.	Immediately following the procedure
Secondary	Adenoma detection rates	Histopathological testing and reporting will follow standard practices and adenoma detection rates will be documented and compared between study arms.	Immediately following the procedure