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

• Sponsor: London North West Healthcare NHS Trust (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04710706
• Collaborator: (none)
• Enrollment: 224
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.8
• Patients Per Site Per Month: 14.1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Colon Polyp	Other: Colonoscopy insertion technique used during procedure	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 224 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Water-only Versus Water-CO2 (Hybrid) Colonoscopy Insertion Technique (WAVE): a Randomised Study
• Actual Study Start Date: Mar 6, 2021
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Water-alone colonoscopy (water exchange technique) 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.	Other: Colonoscopy insertion technique used during procedure; Each arm is using a different colonoscopy insertion technique: either water-alone colonoscopy or water-CO2 colonoscopy.
Active Comparator: Water-CO2 hybrid colonoscopy (modified water immersion technique) 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.	Other: Colonoscopy insertion technique used during procedure; Each arm is using a different colonoscopy insertion technique: either water-alone colonoscopy or water-CO2 colonoscopy.

Outcome Measures

Primary Outcome Measures

1. Insertion time [During procedure]

   Time taken to insert the colonoscope

2. Total procedure time [During procedure]

   Time taken to insert and withdraw the colonoscope

Secondary Outcome Measures

1. Caecal intubation rate [During procedure]

   The proportion of procedures where the caecum is reached

2. Patient discomfort scores [Immediately after procedure]

   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.

3. Loop formation [During procedure]

   Scopeguide appearance will be used to evaluate number of loops formed

4. Adenoma detection rate [1 week after procedure with results of histology]

   A measure of the number of adenomas detected during colonoscopy

5. Serrated polyp detection rate [1 week after procedure with results of histology]

   A measure of the number of serrated polyps detected during colonoscopy

6. Number of ancilliary procedures [During procedure]

   The number of patient repositions and abdominal pressure episodes required during the procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Aged 18 years or older

• Capacity to consent

Exclusion Criteria:

• Pregnancy

• Previous bowel surgery

• Unable to consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Mark's Hospital	Harrow		United Kingdom

Sponsors and Collaborators

• London North West Healthcare NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: London North West Healthcare NHS Trust
• ClinicalTrials.gov Identifier: NCT04710706
• Other Study ID Numbers: v1.7 30.04.20
• First Posted: Jan 15, 2021
• Last Update Posted: Nov 5, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by London North West Healthcare NHS Trust: COLONOSCOPY; ENDOSCOPY
• Additional relevant MeSH terms: Colonic Polyps

Study Results

No Results Posted as of Nov 5, 2021