Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209349
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Veteran Affairs Sepulveda Ambulatory Care Cente
Information provided by (Responsible Party):
Kelowna Gastroenterology Associates

Tracking Information
First Submitted Date  ICMJE June 14, 2017
First Posted Date  ICMJE July 6, 2017
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE June 14, 2017
Estimated Primary Completion Date December 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
Full colon exam [ Time Frame: Immediately following the procedure ]
Ability for patient to receive full exam of the colon with minimal discomfort
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03209349 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
  • Recalled Discomfort [ Time Frame: Immediately following the procedure ]
    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.
  • Adenoma detection rates [ Time Frame: Immediately following the procedure ]
    Histopathological testing and reporting will follow standard practices and adenoma detection rates will be documented and compared between study arms.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of Cecal Intubation Rates and Pain Levels Between Water Exchange and Air Insufflation Flexible Sigmoidoscopy
Official Title  ICMJE Investigation of Cecal Intubation Rates and Pain Levels Between Water Exchange and Air Insufflation Flexible Sigmoidoscopy: A Randomized Controlled Study
Brief 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.

Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

The study interviewer and the patient will be blinded to the procedure type both during and following the procedure type both during and following the procedure by concealing the monitors and relevant equipment from their sight.

The physician performing the procedure will be blinded to the procedure type until the patient is brought into the procedure room. They will open the allocation envelope once the patient has been placed and positioned on the procedure bed.

Neither the patient, the RN, nor the research assistant, who will be conducting the follow-up interviews, will be informed of the study arm. Patient assignment will be managed by the study project manager and will be kept in a password protected file and will remain separate from other study data until the time of the final analysis.

Primary Purpose: Screening
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Procedure: Water Exchange Sigmoidoscopy
    See arm description.
  • Procedure: Air Insufflation Sigmoidoscopy
    See arm description.
Study Arms  ICMJE
  • Experimental: Water Exchange Sigmoidoscopy

    As per standard practices, the patient will be walked to the procedure room and positioned in the left lateral position on the procedure bed, without pre-operative anesthesia. The procedures will be completed within the ambulatory endoscopy clinic at Kelowna General Hospital. The study will use the same colonoscopes that are already being used at KGH for colonoscopy. These are the Olympus 190 series colonoscopes. They can and will be fitted to support both water and air exchange.

    For patients assigned the water exchange intervention arm, the insertion of the scope will be followed by infusion and suction of water to minimally distend the lumen. If the lumen does not open, the instrument will be retracted slightly and the infusion started again. As the scope is inserted and progressed through the intestinal lumen some of the infused water will be suctioned back constantly, exchanging clean for opaque water.

    Intervention: Procedure: Water Exchange Sigmoidoscopy
  • Active Comparator: Air Insufflation Sigmoidoscopy

    As per standard practices, the patient will be walked to the procedure room and positioned in the left lateral position on the procedure bed, without pre-operative anesthesia. The procedures will be completed within the ambulatory endoscopy clinic at Kelowna General Hospital. The study will use the same colonoscopes that are already being used at KGH for colonoscopy. These are the Olympus 190 series colonoscopes. They can and will be fitted to support both water and air exchange.

    For patients assigned to the air insufflation intervention arm, extended sigmoidoscopy will be performed with the minimum insufflation required to reach the cecum.

    Intervention: Procedure: Air Insufflation Sigmoidoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 9, 2020
Estimated Primary Completion Date December 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Brent Parker, M.Sc 250-469-4881 brent.parker2@interiorhealth.ca
Contact: Adrian Bak, MD 250-763-6433 adrianbak@mac.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03209349
Other Study ID Numbers  ICMJE 2016-17-078-I
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kelowna Gastroenterology Associates
Study Sponsor  ICMJE Kelowna Gastroenterology Associates
Collaborators  ICMJE Veteran Affairs Sepulveda Ambulatory Care Cente
Investigators  ICMJE
Principal Investigator: Rafael Perini, MD Kelowna General Hospital, Department of Gastroenterology
Principal Investigator: Adrian Bak, MD Kelowna General Hospital, Department of Gastroenterology
PRS Account Kelowna Gastroenterology Associates
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP