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OpenTrials
Completed

NCT Number: NCT01633333

Water Exchange Versus Carbon Dioxide for Colonoscopy

Colonoscopy is commonly used in screening for colorectal cancer. A refined technique of colonoscopy involving the use of water as the sole modality to aid colonoscope insertion, water exchange, has been described in recent research papers to decrease patient discomfort and pain, and to reduce the need for sedation during colonoscopy when compared with standard air insufflation. Carbon dioxide insufflation has been described to decrease patient discomfort after colonoscopy. No randomized trial has so far compared the use of water exchange to carbon dioxide insufflation. Our hypothesis is that water exchange inflicts less discomfort to patients undergoing colonoscopy than carbon dioxide insufflation. Patients undergoing screening colonoscopy in two centers in Norway, one center in Poland and one center in The Netherlands will be enrolled and randomized to examination of either of the two methods.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sorlandet Hospital, Arendal, Norway

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About this study

Single blinded randomized controlled trial.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients scheduled for screening or polyp surveillance colonoscopy
  • Patients accepting sedation on demand

Exclusion criteria

  • Demand for sedation/analgesia before the start of the procedure
  • Previous partial or total colonic resection
  • Pregnancy
  • Unwilling/unable to provide informed consent

Treatment and study plan

Water exchange colonoscopy

Other

Water is infused and suctioned in a systematic fashion to obtain luminal view and for cleansing of the colon to facilitate colonoscope insertion. The carbon dioxide pump is turned off, only to be turned on during withdrawal from the cecum.

Other names: Water exchange

Carbon dioxide insufflation

Other

Carbon dioxide insufflation to obtain luminal view to facilitate colonoscope insertion, considered to be standard procedure.

Other names: Carbon dioxide

Primary outcomes

  1. Pain during colonoscopy

    Time frame: 1 hour

    Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure.

Secondary outcomes

  1. Pain during colonoscopy

    Time frame: 30 minutes

    Patients will be asked to report pain during colonoscopy to an unblinded study assistant.

  2. Cecal intubation rate

    Time frame: 1 hour

    Cecal intubation rate is defined as successful completion of colonoscopy insertion. This will be analyzed on an intention-to-treat basis according to group allocation.

  3. Cecal intubation time

    Time frame: 1 hour

    The time taken to complete insertion of the colonoscope.

  4. Adenoma detection rate

    Time frame: 1 hour

    Detection of adenomas during each colonoscopy procedure

  5. Polyp detection rate

    Time frame: 1 hour

    Detection of any colonic polyp, irrespective of histologic type, during each procedure.

  6. Dose of medication

    Time frame: 1 hour

    Dose of sedative and analgesic medication needed to complete the colonoscopy.

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Collaborators

  • Erasmus Medical Center
  • Maria Sklodowska-Curie National Research Institute of Oncology
  • South-Eastern Norway Regional Health Authority

Registry information

Official study title

Water Exchange Versus Carbon Dioxide Insufflation to Improve Colonoscopy Screening - a Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 4, 2012
Registry last updated
Feb 12, 2014

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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