Yes, now there is a better and safer solution for prepping patients for any type of colon examinations. Much, much higher patient compliance and patient/physician satisfaction.

Dr. David Graham, a member of our medical advisory board, who is considered one of the nation's top fifty most influential Gastroenterologists and Dr. Kamran Ayub, headed a recent study. This was a small study based on proving the efficacy and desirability for the patient/physician with the colonoscopy prep. All work was done at the VA Hospital, Houston.

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Digestive Disease Week April 2000, Part 2 · Volume 51 · Number 4

*3423 PULSED IRRIGATION EVACUATION: A BETTER TECHNIQUE FOR COLON CLEANSING?

Kamran Ayub, Waqar Quershi, Rosetta Brown,
Rhonda A. Cole, David Y. Graham
VA Med Ctr, Houston, TX.

Background: The first, and possibly most critical, step in colonoscopy is to have an adequately prepared colon. Unfortunately, none of the currently used colon cleansing regimens are completely satisfactory both in terms of patient complaints of unpleasant side effects and in terms of failure to provide a clean colon.

The failure rate with traditional preparation is typically 10 to 30 %. We used the Pulsed Irrigation Evacuation (PIE) device for colon cleansing. This device administers warm tap water through a cuffed speculum with microprocessor-timed pulses of inflow and outflow. The rehydrated fecal matter is collected in a closed system that is discarded. The PIE technique is FDA approved for the management of fecal impaction.

We hypothesized that use of PIE should result in rapid colon cleansing for colonoscopy with minimal patient discomfort.

Methods: Consecutive outpatients scheduled for colonoscopy were offered the opportunity to participate. Main exclusion criteria were suspected bowel obstruction, previous colon resection, and severe congestive heart failure.

Patients were advised to take clear liquids after 1 PM on the day prior to examination, one bottle of magnesium citrate (165 ml) the evening prior to examination and were kept NPO after midnight. Upon arrival to the Endoscopy suite, PIE was performed until the return was clear, followed by colonoscopy.

Endoscopic photographs were taken in each segment of the colon, and video recordings were made. Patient discomfort during colon cleansing was assessed by a questionnaire. The quality of colon cleansing was graded using a previously used scoring system during the procedure. Two Endoscopists also independently graded the quality of colon cleansing based on the photographs/video.

Results: 20 consecutive patients participated (mean age = 60 yr - range of 45-80 yr). PIE was well tolerated. The only side effect was mild abdominal cramps during large pulses. Colonoscopy preparation was complete to the cecum or terminal ileum in all.

Colon cleansing was graded as acceptable or better in all (100% success: excellent = 4 patients, good = 15 patients, acceptable = 1 patient). The average time for cleansing was 25 minutes (range 20 to 35) and typically, approximately 6 gallons of water was required. Five patients had previous colonoscopy with GoLytely preparation and all preferred PIE.

Conclusions: PIE Prep results in optimal and rapid colon cleansing while causing minimal patient discomfort. It could be used as a primary colon preparation or for same day cleansing of those with poor traditional preparation.

The results indicated that there was no comparison between the PIE* Prep and the traditional means. Our method was accepted much higher for both the patient/physician.

A much larger study with Dr. David Graham is being funded by the "American College of Gastroenterology".

In this much larger study the Medical team is comparing Golytley, Phosphosoda, the traditional chemical Colon prep, against the PIE* Prep and comparing their effectiveness and patient satisfaction. Dr. Graham reports a total of 80 patients have been completed so far with PIE Prep showing excellent results over the chemical methods. Dr. Graham intends to include 500 patients and expects to have it completed by December 2001.

How is the PIE* Prep performed?

The patient is scheduled for the colonoscopy. The night before the colonoscopy, they are instructed to take two tablespoons of Milk of Magnesia. Then the patient arrives at the Gastroenterologist office one hour early. A nurse, using the PIE* System, has the patient to lie on a table and the PIE* Speculum is inserted into the rectum.



The speculum is designed to inflate and fill the rectal vault.
Then the computer driven PIE* System begins infusing small quantities of water with the water being rapidly pulsed to break up and clean the entire colon area. The quantities of water are increased so that the entire colon can be cleaned up to the ileocecal valve.

The procedure typically takes about 30-45 minutes!

Is the PIE* Procedure comfortable to the patient?
Yes. In fact many of the patients find the procedure so relaxing that they fall asleep.

In fact, the patient experiences no ill effects and can usually return to their normal activities immediately after the colonoscopy.

Is the PIE* Prep always successful?
Yes. There's never been a failed PIE* Prep.

It is the PIE* Prep always reimbursable?
No. We are being issued a CPT Code in January 2002 for fecal impaction removal without anesthesia. We're working to have the AMA also modify this code or to establish a separate Code for Colonoscopy Prep.

Patients will pay out of their own pocket.

We believe that there are many patients who dislike the traditional oral prep so much that they will pay out of their pocket for this alternative. From a recent survey, we found over 50%, when given an alternative, would gladly pay out of their pocket.

What if they patient arrives at the Gastroenterologist office and has used traditional oral prep and is not clean, can the PIE* Prep solve this problem?

Absolutely, with a PIE* System in your office, the patient can remain on your colonoscopy table and in only a few minutes be totally clean.

You are now able to maintain their scheduled appointment about rescheduling.

Many Gastroenterologist have told us that some of their patients absolutely refused to reschedule and go through the oral prep again. Plus, keeping the appointment for the Gastroenterologist means that the schedule appointment was not lost.