Effectiveness of Stiffening Wire in Colonoscopy With Pre-Owned Colonoscopes

Study Overview
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Brief Summary
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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.

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

Conditions
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Colonoscopy

Intervention / Treatment
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* Device: Colonoscope stiffening device
* Device: Colonoscope stiffening device
* Device: Colonoscope stiffening device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stiffening wire only if difficulty<br>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<br>* 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.<br>* Other names: ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical;|
| Experimental: Stiffening wire #1 transverse colon<br>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<br>* 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.<br>* Other names: ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical;|
| Experimental: Stiffening wire #2 transverse colon<br>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<br>* 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.<br>* Other names: ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cecal intubation |  | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to cecal intubation |  | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intubation rate, intubation time, stiffening device, stiffening wire