Effectiveness of Stiffening Wire in Colonoscopy With Pre-Owned Colonoscopes

August 2, 2011 updated by: Cornwall Regional Hospital

Effectiveness of a Proprietary Intraluminal Stiffening Wire in Decreasing Procedure Time and Improving Cecal Intubation Rate With Pre-owned Colonoscopes; a Randomized, Controlled Trial

The study aims to determine whether a proprietary, FDA approved stiffening wire improves the efficiency of colonoscopy (that is, decreases the duration of the procedure) and/or enables complete visualization of the colon in a greater proportion of cases (than when the procedure is performed without it) with old, used colonoscopes.

Colonoscopes are designed with a delicate balance between stiffness and flexibility. Stiffness helps to prevent curling (looping) of the colonoscope in those sections of the colon that are not fixed to the wall of the abdominal cavity and flexibility enables successful negotiation of bends or flexures in the colon. As colonoscopes age, they lose stiffness and this makes it very challenging to advance the colonoscope all the way to the cecum (the upper end of the colon). Even when the cecum is successfully reached, it may take an inordinately long time.

In Jamaica, most endoscopists (General Surgeons and Gastroenterologists) use older, pre-owned colonoscopes imported from the USA, because the average patient and local health insurance companies cannot bear the level of fees that would enable cost recovery for new equipment.

The stiffening wires (in two grades of stiffness) used in this study are passed through the biopsy channel of the colonoscope only after its tip has passed the upper end of the descending colon and entered the transverse colon. The device is safe when used as recommended by the manufacturers (and approved by the FDA), and does not appear to increase risk over and above the risk of colonoscopy with the unassisted colonoscope. Although the device clearly improves the stiffness of the colonoscope, there is no research evidence that it actually works in practice, either to improve cecal intubation rate or to decrease procedure time. It is therefore also unclear whether the possible benefit of using the device is achieved if introduced at the first opportunity allowed by the manufacturers or only after difficulty is encountered with the unassisted colonoscope.

In this study, patients are randomly assigned to one of 3 "interventions". One group has colonoscopy performed with the colonoscope alone and the wires are only introduced if there is difficulty advancing the colonoscope after it has passed into the transverse colon ("difficulty" defined as failure to advance the tip of the colonoscope after 5 minutes). In the 2nd and 3rd groups, the assigned wire will be introduced as soon as the colonoscope enters the transverse colon and is removed if "difficulty" is encountered, as defined above. The different phases of colonoscopy will be timed with a stop watch and when a sufficient number of patients has been accrued, the investigator will be able to compare the time it takes to complete the procedure with and without the wires as well as the proportion of cases in which the cecum was reached with and without the assistance of the wires.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jamaica
    • St. James
      • Montego Bay, St. James, Jamaica
        • Mobay Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults 18 years and older having screening or diagnostic colonoscopy

Exclusion Criteria:

  • Previous hysterectomy
  • Previous radical prostatectomy
  • Clinical presentation or imaging study suggesting presence of lesion that could obstruct passage of colonoscope

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stiffening wire only if difficulty
Colonoscopy is performed with the unassisted colonoscope. The stiffening wire is introduced only if there is difficulty advancing the colonoscope and only after the tip has passed the splenic flexure. Difficulty is defined as failure to advance the tip of the scope after 5 minutes of trying.
Device: Colonoscope stiffening device
Colonoscopy is performed with the unassisted colonoscope (Olympus CF-100TL). The "standard" stiffening wire is introduced only if there is difficulty advancing the colonoscope and only after the tip has passed the splenic flexure. Difficulty is defined as failure to advance the tip of the scope after 5 minutes of trying. If difficulty is again encountered, the "firm" wire replaces the "standard" wire. Further difficulty requires removal of the firm wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Device: Colonoscope stiffening device
"Standard" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the "standard" wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "firm" wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Device: Colonoscope stiffening device
"Firm" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "standard" wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Experimental: Stiffening wire #1 transverse colon
Colonoscopy is started with the unassisted colonoscope. Stiffening wire #1 is introduced on entry of the tip of the colonoscope into the transverse colon.
Device: Colonoscope stiffening device
Colonoscopy is performed with the unassisted colonoscope (Olympus CF-100TL). The "standard" stiffening wire is introduced only if there is difficulty advancing the colonoscope and only after the tip has passed the splenic flexure. Difficulty is defined as failure to advance the tip of the scope after 5 minutes of trying. If difficulty is again encountered, the "firm" wire replaces the "standard" wire. Further difficulty requires removal of the firm wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Device: Colonoscope stiffening device
"Standard" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the "standard" wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "firm" wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Device: Colonoscope stiffening device
"Firm" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "standard" wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Experimental: Stiffening wire #2 transverse colon
Colonoscopy is started with the unassisted colonoscope. Stiffening wire #2 is introduced on entry of the tip of the colonoscope into the transverse colon.
Device: Colonoscope stiffening device
Colonoscopy is performed with the unassisted colonoscope (Olympus CF-100TL). The "standard" stiffening wire is introduced only if there is difficulty advancing the colonoscope and only after the tip has passed the splenic flexure. Difficulty is defined as failure to advance the tip of the scope after 5 minutes of trying. If difficulty is again encountered, the "firm" wire replaces the "standard" wire. Further difficulty requires removal of the firm wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Device: Colonoscope stiffening device
"Standard" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the "standard" wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "firm" wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Device: Colonoscope stiffening device
"Firm" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "standard" wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cecal intubation
Time Frame: 10 months
10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to cecal intubation
Time Frame: 10 months
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cornwall Regional Hospital

Collaborators

MoBay Hope Medical Center, Jamaica

Investigators

  • Principal Investigator: Jeffrey M East, MD, Cornwall Regional Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

April 29, 2010

First Submitted That Met QC Criteria

April 30, 2010

First Posted (Estimate)

May 3, 2010

Study Record Updates

Last Update Posted (Estimate)

August 3, 2011

Last Update Submitted That Met QC Criteria

August 2, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JE-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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