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

NCT ID: NCT04710706

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-06
• Study Completion Date: 2022-06-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Colonoscopy insertion technique used during procedure

Intervention Type: 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)

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.

Group Type: ACTIVE_COMPARATOR

Colonoscopy insertion technique used during procedure

Intervention Type: OTHER

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

Interventions

Colonoscopy insertion technique used during procedure

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged 18 years or older
• Capacity to consent

Exclusion Criteria

• Pregnancy
• Previous bowel surgery
• Unable to consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

London North West Healthcare NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St Mark's Hospital

Harrow, , United Kingdom

Countries

United Kingdom

Other Identifiers

v1.7 30.04.20

Identifier Type: -

Identifier Source: org_study_id