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Water-only Versus Water-CO2 (Hybrid) Colonoscopy Insertion Technique (WAVE)

Primary Purpose

Colon Polyp

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Colonoscopy insertion technique used during procedure
Sponsored by
London North West Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Polyp focused on measuring COLONOSCOPY, ENDOSCOPY

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 18 years or older
  • Capacity to consent

Exclusion Criteria:

  • Pregnancy
  • Previous bowel surgery
  • Unable to consent

Sites / Locations

  • St Mark's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Water-alone colonoscopy (water exchange technique)

Water-CO2 hybrid colonoscopy (modified water immersion technique)

Arm Description

During water-alone colonoscopy, gas insufflation (air or CO2) is not allowed during the insertion of the colonoscope to the caecum. Instead, water is used to facilitate the passage of the scope to the caecum. On withdrawal, CO2 is permitted.

During water-CO2 hybrid colonoscopy, the operator has access to both water and CO2. In the left colon, predominately water is used to navigate the sigmoid. Once the splenic flexure is reached, a combination of water and CO2 is used to reach the caecum. On withdrawal, CO2 is permitted.

Outcomes

Primary Outcome Measures

Insertion time
Time taken to insert the colonoscope
Total procedure time
Time taken to insert and withdraw the colonoscope

Secondary Outcome Measures

Caecal intubation rate
The proportion of procedures where the caecum is reached
Patient discomfort scores
Patients will subjectively assess discomfort scores following the procedure using a Visual Analogue Scale (VAS) which ranges from 0 to 10 where a higher score means a worse outcome.
Loop formation
Scopeguide appearance will be used to evaluate number of loops formed
Adenoma detection rate
A measure of the number of adenomas detected during colonoscopy
Serrated polyp detection rate
A measure of the number of serrated polyps detected during colonoscopy
Number of ancilliary procedures
The number of patient repositions and abdominal pressure episodes required during the procedure

Full Information

First Posted
May 12, 2020
Last Updated
October 13, 2022
Sponsor
London North West Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04710706
Brief Title
Water-only Versus Water-CO2 (Hybrid) Colonoscopy Insertion Technique
Acronym
WAVE
Official Title
Water-only Versus Water-CO2 (Hybrid) Colonoscopy Insertion Technique (WAVE): a Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 6, 2021 (Actual)
Primary Completion Date
June 27, 2022 (Actual)
Study Completion Date
June 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London North West Healthcare NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The colonoscopy procedure involves insertion of a thin, flexible tube with a tiny camera inside (colonoscope) passed inside the bowel. To allow passage of the colonoscope and adequate visualisation of the lining of the bowel wall a range of techniques can be used. During colonoscopy, you can distend the colon with water, CO2 and air. Air is no longer recommended for gas insufflation during colonoscopy as it causes pain and excess bowel distention. So the options are water and/or CO2 but it is not entirely clear which combination is the best and at what point during the colonoscopy. In practice, a hybrid technique where both CO2 and water are used during the colonoscopy in used. Here, water is exclusively used to help navigate the sigmoid colon with air pockets suctioned and turbid water exchanged with clean water. From splenic flexure to caecum a mixture of water and CO2 is used. The aim of this study is to assess procedure comfort and efficiency of two different colonoscopy insertion techniques: water-alone insertion of the colonoscope (gas insufflation not allowed on insertion; water exchange technique) versus water-CO2 hybrid insertion (water used predominately to splenic flexure with water/CO2 used to caecum; modified water immersion technique).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Polyp
Keywords
COLONOSCOPY, ENDOSCOPY

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water-alone colonoscopy (water exchange technique)
Arm Type
Active Comparator
Arm Description
During water-alone colonoscopy, gas insufflation (air or CO2) is not allowed during the insertion of the colonoscope to the caecum. Instead, water is used to facilitate the passage of the scope to the caecum. On withdrawal, CO2 is permitted.
Arm Title
Water-CO2 hybrid colonoscopy (modified water immersion technique)
Arm Type
Active Comparator
Arm Description
During water-CO2 hybrid colonoscopy, the operator has access to both water and CO2. In the left colon, predominately water is used to navigate the sigmoid. Once the splenic flexure is reached, a combination of water and CO2 is used to reach the caecum. On withdrawal, CO2 is permitted.
Intervention Type
Other
Intervention Name(s)
Colonoscopy insertion technique used during procedure
Intervention Description
Each arm is using a different colonoscopy insertion technique: either water-alone colonoscopy or water-CO2 colonoscopy.
Primary Outcome Measure Information:
Title
Insertion time
Description
Time taken to insert the colonoscope
Time Frame
During procedure
Title
Total procedure time
Description
Time taken to insert and withdraw the colonoscope
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
Caecal intubation rate
Description
The proportion of procedures where the caecum is reached
Time Frame
During procedure
Title
Patient discomfort scores
Description
Patients will subjectively assess discomfort scores following the procedure using a Visual Analogue Scale (VAS) which ranges from 0 to 10 where a higher score means a worse outcome.
Time Frame
Immediately after procedure
Title
Loop formation
Description
Scopeguide appearance will be used to evaluate number of loops formed
Time Frame
During procedure
Title
Adenoma detection rate
Description
A measure of the number of adenomas detected during colonoscopy
Time Frame
1 week after procedure with results of histology
Title
Serrated polyp detection rate
Description
A measure of the number of serrated polyps detected during colonoscopy
Time Frame
1 week after procedure with results of histology
Title
Number of ancilliary procedures
Description
The number of patient repositions and abdominal pressure episodes required during the procedure
Time Frame
During procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18 years or older Capacity to consent Exclusion Criteria: Pregnancy Previous bowel surgery Unable to consent
Facility Information:
Facility Name
St Mark's Hospital
City
Harrow
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Water-only Versus Water-CO2 (Hybrid) Colonoscopy Insertion Technique

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