Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT03160859

Collaborator

VA Northern California Health Care System (U.S. Fed), VA Palo Alto Health Care System (U.S. Fed)

256

Enrollment

Locations

Arms

65.7

Anticipated Duration (Months)

85.3

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study to compare two different, but normally, used methods of colonoscopy in patients undergoing colonoscopy without sedation. There will be two arms in this study: WE (water exchange) control, and WE (water exchange) plus cap (placed at tip of the colonoscope). The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The control method will use water instead of air during insertion of the colonoscope. The study method will use a cap that will fit onto the end of the colonoscope plus water during insertion of the colonoscope. This study will assess if the study method is less painful than the control method.

Condition or Disease	Intervention/Treatment	Phase
Unsedated Colonoscopy Water Exchange Colonoscopy Cap Colonoscopy Pain	Other: Control Device: Study method	N/A

Detailed Description

This will be a multi-VA site, unblinded investigators, prospective randomized control trial (RCT). Randomization (WE, WE + cap) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order set up by statistics consultant) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two arms (WE, WE + cap) to see which one is less painful.

Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified type of colonoscopy (screening, surveillance, diagnostic). All subjects will have scheduled unsedated colonoscopy as a result of lack of escort or personal preference for no sedation. Randomization will be set up by statistics consultant.

Control Method: One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.

Study method: The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a cap, fitted to the colonoscope per manufacturer instruction.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

256 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This will be a multi-VA site, prospective RCT to compare different methods with 2 arms to determine which is less painful: water alone or water plus cap. Randomization will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site. Control Method: Involves unsedated colonoscopy with water exchange. Residual air will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion. Study method: Involves unsedated colonoscopy with water exchange and the addition of a commercially available accessory fitted onto the colonoscope.This will be a multi-VA site, prospective RCT to compare different methods with 2 arms to determine which is less painful: water alone or water plus cap. Randomization will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site. Control Method: Involves unsedated colonoscopy with water exchange. Residual air will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion. Study method: Involves unsedated colonoscopy with water exchange and the addition of a commercially available accessory fitted onto the colonoscope.

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Prospective RCT of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy

Actual Study Start Date :

Jun 8, 2018

Anticipated Primary Completion Date :

Oct 29, 2022

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Control Method One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.	Other: Control Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion. Other Names: Water exchange method
Other: Study Method The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.	Device: Study method Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope. Other Names: Water exchange method plus cap

Arm

Intervention/Treatment

Other: Control Method

One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.

Other: Control

Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.

Other Names:

Water exchange method

Other: Study Method

The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.

Device: Study method

Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.

Other Names:

Water exchange method plus cap

Outcome Measures

Primary Outcome Measures

Primary Outcome Variable: Real time maximum insertion pain [48 months]
Pain during insertion reported to the unblinded assisting nurse, visual analogue scale, VAS: 0=none, 10=most severe. The highest pain score will be tabulated for analysis. Timing of data collection will be at the discretion of the nurse to minimize bias by colonoscopist behavior.

Secondary Outcome Measures

Secondary Outcome Variables: Proportion with no insertion pain [48 months]
Proportion report no pain during insertion of the colonoscope (quality marker)
Secondary Outcome Measure: Insertion time [48 months]
Time to cecum (clock display on monitor), faster insertion is a quality marker
Secondary Outcome Measure: Proximal colon ADR [48 months]
ADR from cecum to splenic flexure, measure of high quality colonoscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Informed/educated (about pros and cons of the unsedated option) Veterans undergoing:
diagnostic
surveillance (follow up of polyps)
screening (first-time) colonoscopy at participating sites
choosing scheduled unsedated colonoscopy for any reason (lack of escort, personal preference)

Exclusion Criteria:

decline to be randomized
unable to give consent or respond to questionnaires
history of colon surgery
active inflammatory bowel disease
lower gastrointestinal bleeding (except for occult blood or FIT positive in the context of colon cancer screening)
therapeutic colonoscopy (e.g., hemostasis, removal of large polyp)
proctosigmoidoscopy
bidirectional endoscopy
inadequate consumption of bowel preparation
known history of severe diverticulosis or diverticulitis
history of abdominal surgery previously requiring sedation for colonoscopy
current narcotic/anxiolytic medication use
prior unsuccessful experience with unsedated colonoscopy
emergent colonoscopy
evidence of colonic obstruction based on pre-colonoscopy clinical evaluation
current participation in other studies
medical condition that could increase the risk associated with colonoscopy
active cardiac
or pulmonary disease
or other serious disease
medical condition that would preclude a benefit from colonoscopic screening
cancer
or any terminal illness
prosthetic heart valve
anticoagulant therapy
nonmedical problems
psychiatric disorders
excessive use of alcohol
need for special precautions in performing colonoscopy
antibiotic prophylaxis
request of on demand sedation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California	United States	94304-1290
2	VA Northern California Health Care System, Mather, CA	Sacramento	California	United States	95655
3	VA Greater Los Angeles Healthcare System, Sepulveda, CA	Sepulveda	California	United States	91343

Sponsors and Collaborators

VA Office of Research and Development
VA Northern California Health Care System
VA Palo Alto Health Care System

Investigators

Principal Investigator: Felix W. Leung, MD, VA Greater Los Angeles Healthcare System, Sepulveda, CA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT03160859

Other Study ID Numbers:

GAST-015-16S

First Posted:

May 19, 2017

Last Update Posted:

Jun 23, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by VA Office of Research and Development

unsedated colonoscopy

water exchange colonoscopy

cap

colonoscopy pain

Study Results

No Results Posted as of Jun 23, 2022