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

NCT04710706 | Completed

• 1 other identifier: v1.7 30.04.20
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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).

Conditions

Colon Polyp

Keywords

COLONOSCOPY; ENDOSCOPY

Outcome Measures

Primary Outcomes (2)

• Insertion time

  Time taken to insert the colonoscope

  During procedure

• Total procedure time

  Time taken to insert and withdraw the colonoscope

  During procedure

Secondary Outcomes (6)

• Caecal intubation rate

  During procedure

• Patient discomfort scores

  Immediately after procedure

• Loop formation

  During procedure

• Adenoma detection rate

  1 week after procedure with results of histology

• Serrated polyp detection rate

  1 week after procedure with results of histology

Study Arms (2)

Water-alone colonoscopy (water exchange technique)

ACTIVE COMPARATOR

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

Water-CO2 hybrid colonoscopy (modified water immersion technique)

ACTIVE COMPARATOR

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

Interventions

Colonoscopy insertion technique used during procedure OTHER

Each arm is using a different colonoscopy insertion technique: either water-alone colonoscopy or water-CO2 colonoscopy.

Water-CO2 hybrid colonoscopy (modified water immersion technique); Water-alone colonoscopy (water exchange technique)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Capacity to consent

You may not qualify if:

• Pregnancy
• Previous bowel surgery
• Unable to consent

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

St Mark's Hospital

Harrow, United Kingdom

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: January 15, 2021
• Study Start: March 6, 2021
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: October 14, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)