A Trial of Segmental Stiffening Wires to Improve Colonoscopy

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Colonoscopy can be challenging to perform and painful for the patient due to looping of the colonoscope. Looping occurs when further insertion of the colonoscope does not result in advancement of the tip, but instead results in a loop forming in the shaft of the colonoscope. Many attempts have been made with varied success to solve this problem. To date there is no perfect solution to looping. Since endoscopic examination of the colon is the gold standard for colon cancer screening and diagnosing many diseases of the colon, providing a device that could prevent looping and assure a more complete and more comfortable examination would be valuable. We have developed an experimental device that has not been approved outside of the context of this study known as the Segmental Stiffening Wire (SSW) to prevent re-looping. This wire will be utilized if looping occurs by passing it through the biopsy channel of the endoscope. The wire has a 15-25 inch area of increased thickness and stiffness. The stiffened section of the wire can be advanced into areas of looping, after reduction, in an effort to prevent re-looping. We will conduct a pilot study of the SSW that will include approximately 10 healthy volunteers who will undergo colonoscopy using an adult colonoscope and, if looping occurs, the SSW. This will allow the study endoscopists to gain familiarity with the device and will use fluoroscopy to document looping and to determine if the device prevents re-looping. If unable to obtain sufficient volunteers willing to undergo dual colonoscopy, then patients willing to undergo single colonoscopy will be included and their procedures will be done either with or without the SSW in a random fashion. The endpoints will be cecal intubation time; quantity of sedation/analgesia; number of required ancillary maneuvers; pain/sedation as measured by the visual analog pain scale, a modified COMFORT scale, and the Ramsey Sedation Scale; vital sign changes; and the endoscopists subjective assessment of procedure difficulty and usefulness of the SSW. Only seven patients have been enrolled into the first phase of the study. Therefore, no research accomplishments can be summarized at this time.