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Water Exchange Versus Carbon Dioxide for Colonoscopy

Primary Purpose

Colorectal Cancer, Colorectal Adenomas, Colorectal Polyps

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Water exchange colonoscopy
Carbon dioxide insufflation
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Colonoscopy, Colorectal cancer, Colorectal adenomas, Pain

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sorlandet Hospital
  • Sorlandet Hospital
  • The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Water exchange

Carbon dioxide insufflation

Arm Description

Colonoscopy with water exchange as the sole modality to reach the cecum. Carbon dioxide can be used in case of intubation failure with the test method.

Carbon dioxide insufflation will be used in standard fashion to reach the cecum.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain during colonoscopy
Patients will be asked to report pain during colonoscopy to an unblinded study assistant.
Cecal intubation rate
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.
Cecal intubation time
The time taken to complete insertion of the colonoscope.
Adenoma detection rate
Detection of adenomas during each colonoscopy procedure
Polyp detection rate
Detection of any colonic polyp, irrespective of histologic type, during each procedure.
Dose of medication
Dose of sedative and analgesic medication needed to complete the colonoscopy.

Full Information

First Posted
June 29, 2012
Last Updated
February 11, 2014
Sponsor
Sorlandet Hospital HF
Collaborators
South-Eastern Norway Regional Health Authority, Maria Sklodowska-Curie National Research Institute of Oncology, Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01633333
Brief Title
Water Exchange Versus Carbon Dioxide for Colonoscopy
Official Title
Water Exchange Versus Carbon Dioxide Insufflation to Improve Colonoscopy Screening - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF
Collaborators
South-Eastern Norway Regional Health Authority, Maria Sklodowska-Curie National Research Institute of Oncology, Erasmus Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Single blinded randomized controlled trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Adenomas, Colorectal Polyps, Pain
Keywords
Colonoscopy, Colorectal cancer, Colorectal adenomas, Pain

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
473 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water exchange
Arm Type
Experimental
Arm Description
Colonoscopy with water exchange as the sole modality to reach the cecum. Carbon dioxide can be used in case of intubation failure with the test method.
Arm Title
Carbon dioxide insufflation
Arm Type
Active Comparator
Arm Description
Carbon dioxide insufflation will be used in standard fashion to reach the cecum.
Intervention Type
Other
Intervention Name(s)
Water exchange colonoscopy
Other Intervention Name(s)
Water exchange
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Carbon dioxide insufflation
Other Intervention Name(s)
Carbon dioxide
Intervention Description
Carbon dioxide insufflation to obtain luminal view to facilitate colonoscope insertion, considered to be standard procedure.
Primary Outcome Measure Information:
Title
Pain during colonoscopy
Description
Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Pain during colonoscopy
Description
Patients will be asked to report pain during colonoscopy to an unblinded study assistant.
Time Frame
30 minutes
Title
Cecal intubation rate
Description
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.
Time Frame
1 hour
Title
Cecal intubation time
Description
The time taken to complete insertion of the colonoscope.
Time Frame
1 hour
Title
Adenoma detection rate
Description
Detection of adenomas during each colonoscopy procedure
Time Frame
1 hour
Title
Polyp detection rate
Description
Detection of any colonic polyp, irrespective of histologic type, during each procedure.
Time Frame
1 hour
Title
Dose of medication
Description
Dose of sedative and analgesic medication needed to complete the colonoscopy.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjetil K Garborg, MD
Organizational Affiliation
Sorlandet Hospital HF Kristiansand, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sorlandet Hospital
City
Arendal
Country
Norway
Facility Name
Sorlandet Hospital
City
Kristiansand
ZIP/Postal Code
N-4604
Country
Norway
Facility Name
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
City
Warsaw
Country
Poland

12. IPD Sharing Statement

Citations:
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16307622
Citation
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Water Exchange Versus Carbon Dioxide for Colonoscopy

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