Effectiveness of Stiffening Wire in Colonoscopy With Pre-Owned Colonoscopes

This study has been terminated.
(Colonoscope being used in study not repairable at economic cost.)
Sponsor:
Collaborator:
MoBay Hope Medical Center, Jamaica
Information provided by:
Cornwall Regional Hospital
ClinicalTrials.gov Identifier:
NCT01115010
First received: April 29, 2010
Last updated: August 2, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Colonoscopy
Device: Colonoscope stiffening device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Effectiveness of a Proprietary Intraluminal Stiffening Wire in Decreasing Procedure Time and Improving Cecal Intubation Rate With Pre-owned Colonoscopes; a Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Cornwall Regional Hospital:

Primary Outcome Measures:
  • Cecal intubation [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to cecal intubation [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: December 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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
"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 Name: 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
"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 Name: ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115010

Locations
Jamaica
Mobay Hope Medical Center
Montego Bay, St. James, Jamaica
Sponsors and Collaborators
Cornwall Regional Hospital
MoBay Hope Medical Center, Jamaica
Investigators
Principal Investigator: Jeffrey M East, MD Cornwall Regional Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey East, Cornwall Regional Hospital
ClinicalTrials.gov Identifier: NCT01115010     History of Changes
Other Study ID Numbers: JE-1
Study First Received: April 29, 2010
Last Updated: August 2, 2011
Health Authority: Jamaica: Ministry of Health

Keywords provided by Cornwall Regional Hospital:
intubation rate
intubation time
stiffening device
stiffening wire

ClinicalTrials.gov processed this record on September 29, 2014