Effectiveness of Stiffening Wire in Colonoscopy With Pre-Owned Colonoscopes

NCT01115010 | Terminated

• 1 other identifier: JE-1
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colonoscopy

Keywords

intubation rate; intubation time; stiffening device; stiffening wire

Outcome Measures

Primary Outcomes (1)

• Cecal intubation

  10 months

Secondary Outcomes (1)

• Time to cecal intubation

  10 months

Study Arms (3)

Stiffening wire only if difficulty

EXPERIMENTAL

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

Stiffening wire #1 transverse colon

EXPERIMENTAL

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

Stiffening wire #2 transverse colon

EXPERIMENTAL

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

Interventions

Colonoscope stiffening device 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.

Also known as: ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical

Stiffening wire only if difficulty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years and older having screening or diagnostic colonoscopy

You may not qualify if:

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

Sponsors & Collaborators

• Cornwall Regional Hospital: lead
• MoBay Hope Medical Center, Jamaica: collaborator

Study Sites (1)

Mobay Hope Medical Center

Montego Bay, Saint James Parish, Jamaica

Location

Related Publications (8)

• Odori T, Goto H, Arisawa T, Niwa Y, Ohmiya N, Hayakawa T. Clinical results and development of variable-stiffness video colonoscopes. Endoscopy. 2001 Jan;33(1):65-9. doi: 10.1055/s-2001-11174.

  PMID: 11204990 BACKGROUND

• Shah SG, Saunders BP. Aids to insertion: magnetic imaging, variable stiffness, and overtubes. Gastrointest Endosc Clin N Am. 2005 Oct;15(4):673-86. doi: 10.1016/j.giec.2005.08.011.

  PMID: 16278132 BACKGROUND

• Sivak MV. Gastroenterologic Endoscopy. Second Edition. W.B. Saunders, 1999.

  BACKGROUND

• Zutron Medical. Colonoscope stiffening device. http://zutronmedical.storesecured.com/items/Endoscope-Stiffening-System/list.htm . 2009. Ref Type: Electronic Citation

  BACKGROUND

• Smith PG, Morrow RH. Field Trials of Health Interventions in Developing Countries: A Toolbox. 2nd ed. London: Macmillan Education, 1996.

  BACKGROUND

• Othman MO, Bradley AG, Choudhary A, Hoffman RM, Roy PK. Variable stiffness colonoscope versus regular adult colonoscope: meta-analysis of randomized controlled trials. Endoscopy. 2009 Jan;41(1):17-24. doi: 10.1055/s-0028-1103488. Epub 2009 Jan 21.

  PMID: 19160154 BACKGROUND

• Baron TH. The variable stiffness colonoscope: a scope for all seasons? Am J Gastroenterol. 2002 Dec;97(12):2942-3. doi: 10.1111/j.1572-0241.2002.07091.x. No abstract available.

  PMID: 12492173 BACKGROUND

• East JM. Effect of a proprietary intraluminal stiffening wire device on cecal intubation time and rate with used colonoscopes; a randomized, controlled trial. BMC Res Notes. 2013 Feb 4;6:48. doi: 10.1186/1756-0500-6-48.

  PMID: 23379922 DERIVED

Study Officials

• Jeffrey M East, MD

  Cornwall Regional Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 3, 2010
• Study Start: December 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: August 3, 2011

Record last verified: 2011-07

Locations

JA (1)