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Pruitt, Ronald E., M.D.; Ganz, Robert A., M.D.; Brown, Michael, M.D.; Snape, William, M.D.; Peterson, Kathryn A., M.D.; Sattler, James, M.D.; Johnson, David A., M.D.*

American Journal of Gastroenterology: October 2004 - Volume 99 - Issue 10 - p S28–S29
Abstracts Submitted for the 69th Annual Scientific Meeting of the American College of Gastroenterology: October 29–November 3, 2004, Orlando, Florida: ESOPHAGUS

Nashville Medical Research Institute, Nashville, Tennessee; Abbott-Northwestern Hospital, Minneapolis, Minnesota; Rush University Medical Center, Chicago, Illinois; California Pacific Medical Center, San Francisco, California; University of Utah, Salt Lake City, Utah; Torrance Hospital, Torrance, California and Eastern Virginia School of Medicine, Norfolk Virginia.

Purpose: To evaluate the effectiveness of Enteryx treatment of GERD symptoms, postprandial dyspepsia and sleep satisfaction.

Methods: Patients with a GERD diagnosis responsive to proton pump inhibitor therapy were asked to participate in a multicenter prospective study to evaluate the effectiveness, safety and satisfaction of the Enteryx procedure. As part of this study, treatment satisfaction and GERD symptoms are assessed at baseline and at months 1, 3, 6, 12, 24, and 36 post procedure. Treatment satisfaction regarding control of reflux symptoms, response to choice of food and drink, and subjective quality of sleep is assessed using a GERD-specific questionnaire. Symptoms are evaluated using the Velanovich GERD-HRQL instrument. GERD-HRQL scores range from 0-45, with higher scores indicating worse symptoms.

Results: To date, 48 patients have undergone the Enteryx procedure; 56% (27/48) and 31% (15/48) of patients have completed 1 and 3 months follow-up. The average age is 49 years (range 23–72). At 1 month following the Enteryx procedure 68% (19/28) of patients reported that the Enteryx treatment allowed them to sleep better than prior medical treatment. At 3 months 75% (12/16) of patients reported improvement in quality of sleep. At baseline 43% (21/49) of patients reported that their medical regimen provided satisfactory postprandial symptom relief with normal eating habits compared to 68% (19/28) and 73% (11/15) of patients at 1 and 3 months following the Enteryx procedure. Compared to baseline, patients also reported considerable improvement in GERD symptom control as well as overall satisfaction following the Enteryx procedure. The mean GERD-HRQL scores at 1 and 3 months were significantly lower compared to pretreatment scores (21.8 vs 13.0, p = 0.0003; 21.8 vs. 13.1, p <0.0001).

Conclusions: The initial data from this study indicates that following the Enteryx procedure patients have improved GERD-HRQL measurements as well as improved postprandial GERD symptoms and quality of sleep.

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