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OpenTrials
Completed

NCT Number: NCT04710706

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Mark's Hospital

Harrow, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older
  • Capacity to consent

Exclusion criteria

  • Pregnancy
  • Previous bowel surgery
  • Unable to consent

Treatment and study plan

Colonoscopy insertion technique used during procedure

Other

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

Primary outcomes

  1. Insertion time

    Time frame: During procedure

    Time taken to insert the colonoscope

  2. Total procedure time

    Time frame: During procedure

    Time taken to insert and withdraw the colonoscope

Secondary outcomes

  1. Caecal intubation rate

    Time frame: During procedure

    The proportion of procedures where the caecum is reached

  2. Patient discomfort scores

    Time frame: 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

    Time frame: During procedure

    Scopeguide appearance will be used to evaluate number of loops formed

  4. Adenoma detection rate

    Time frame: 1 week after procedure with results of histology

    A measure of the number of adenomas detected during colonoscopy

  5. Serrated polyp detection rate

    Time frame: 1 week after procedure with results of histology

    A measure of the number of serrated polyps detected during colonoscopy

  6. Number of ancilliary procedures

    Time frame: During procedure

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

Sponsors and collaborators

Lead sponsor

London North West Healthcare NHS Trust

Other

Registry information

Official study title

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

Acronym: WAVE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 15, 2021
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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