Investigation of Cecal Intubation Rates and Pain Levels Between Water Exchange and Air Insufflation Flexible Sigmoidoscopy
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Water Exchange Sigmoidoscopy; Air Insufflation Sigmoidoscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): See arm description.; See arm description.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Screening
Keywords: Sigmoidoscopy