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

Colon Polyp Clinical Trial

— WAVE  

Official title:

Water-only Versus Water-CO2 (Hybrid) Colonoscopy Insertion Technique (WAVE): a Randomised Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710706
• Other study ID #: v1.7 30.04.20
• Status: Completed
• Phase: N/A
• Start date: March 6, 2021
• Est. completion date: June 27, 2022

Study information

• Verified date: August 2021
• Source: London North West Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: June 27, 2022
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or older
• Capacity to consent

Exclusion Criteria:

• Pregnancy
• Previous bowel surgery
• Unable to consent

Related Conditions & MeSH terms

• Colon Polyp
• Colonic Polyps

Intervention

Other:
• Colonoscopy insertion technique used during procedure
Each arm is using a different colonoscopy insertion technique: either water-alone colonoscopy or water-CO2 colonoscopy.

Locations

Country	Name	City	State
United Kingdom	St Mark's Hospital	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
London North West Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insertion time	Time taken to insert the colonoscope	During procedure
Primary	Total procedure time	Time taken to insert and withdraw the colonoscope	During procedure
Secondary	Caecal intubation rate	The proportion of procedures where the caecum is reached	During procedure
Secondary	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.	Immediately after procedure
Secondary	Loop formation	Scopeguide appearance will be used to evaluate number of loops formed	During procedure
Secondary	Adenoma detection rate	A measure of the number of adenomas detected during colonoscopy	1 week after procedure with results of histology
Secondary	Serrated polyp detection rate	A measure of the number of serrated polyps detected during colonoscopy	1 week after procedure with results of histology
Secondary	Number of ancilliary procedures	The number of patient repositions and abdominal pressure episodes required during the procedure	During procedure