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      Long-term outcomes after transoral incisionless fundoplication in patients with GERD and LPR symptoms

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          Abstract

          Background

          A retrospective study evaluated safety, symptom resolution, patient satisfaction, and medication use 1–2 years after transoral incisionless fundoplication (TIF) in patients with gastroesophageal reflux disease (GERD) and/or laryngopharyngeal reflux (LPR) symptoms.

          Methods

          Thirty-four patients with a confirmed diagnosis of GERD symptoms that were inadequately controlled by antisecretory medications, and who where either dissatisfied with their current therapy or not willing to continue taking medication, underwent TIF using EsophyX at our community-based hospital. Follow-up assessments were completed in 28 patients.

          Results

          Median age of the study group was 57 (range = 23–77) years, BMI was 25.7 (18.3–36.4) kg/m 2, and 50% were female. All patients had documented chronic GERD for a median 5 (1–20) years and refractory symptoms to proton pump inhibitors (PPIs). Hiatal hernia was present in 75% (21/28) of patients, and 21% (6/28) had erosive esophagitis (LA grade A or B). TIF was performed following a standardized TIF-2 protocol and resulted in reducing hiatal hernia and restoring the natural anatomy of the gastroesophageal (GE) junction (Hill grade I). There were no postoperative complications. At a median 14-months follow-up, 82% (23/28) of patients were off daily PPIs (64% completely off PPIs), and 68% (19/28) were satisfied with their current health condition compared to 4% before TIF. Median GERD Health-Related Quality of Life scores were significantly reduced to 4 (0–25) from 26 (0–45) before TIF ( P < 0.001). Heartburn was eliminated in 65% (17/26) and improved by >50% in 86% (24/28) of patients. Regurgitation was eliminated in 80% (16/20) of patients. Atypical LPR symptoms such as hoarseness, coughing, and throat clearing were eliminated in 63% (17/27) of patients as measured by Reflux Symptom Index scores.

          Conclusion

          Our results in 28 patients confirm the safety and effectiveness of TIF, documenting symptomatic improvement of GERD and LPR symptoms and clinically significant discontinuation of daily PPIs in 82% of patients.

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          Most cited references29

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          The development of the GERD-HRQL symptom severity instrument.

          The Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) instrument was introduced approximately 10 years ago to provide a quantitative method of measuring symptom severity in gastroesophageal reflux disease (GERD). Since that time the instrument has been used to assess treatment response to medication, endoscopic procedures, and surgery for GERD. However, the development of the instrument has progressed over the course of several years, and there is no one source which reviews this progress. The purpose of this article is to summarize the development and testing of the GERD-HRQL. The GERD-HRQL was initially developed to measure the typical symptoms of GERD. It was initially determined to have face validity and subsequent studies assessed its content validity, criterion validity, concurrent validity, predictive validity and construct validity. Reliability was determined by the test-retest method. Responsiveness was determined by the effects of treatment. This instrument is practical, with little administrative burden. There are few missing responses. Because there are 51 possible scores, the instrument has a high level of precision; and because of the response anchors, cannot have a floor effect, and only 4/372 patients reached the highest score of 50, implying little ceiling effect. The instrument has been translated into several languages, and appears valid, reliable and practical in each.
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            Laparoscopic Nissen fundoplication: preliminary report.

            Twelve patients presenting with symptomatic esophagitis associated with hiatal hernia and gastroesophageal reflux underwent operative management under laparoscopic guidance. The antireflux procedure employed was the Nissen fundoplication. The authors completed the operation laparoscopically in nine patients. Postoperatively, patients were evaluated with repeat fiberoptic endoscopy, esophageal manometry, and barium contrast studies. Postoperative results were considered excellent on the basis of these studies and complete control of symptoms. The mortality rate was 0%. The only major operative complication was a pneumonia that occurred in one patient. At 1 month follow-up, six patients were totally asymptomatic. The authors conclude that laparoscopic treatment of gastroesophageal reflux associated with a hiatal hernia is feasible by a procedure that has already proven its value during open surgery.
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              Quality of life scale for gastroesophageal reflux disease.

              Treatment of uncomplicated gastroesophageal reflux disease (GERD) is primarily to improve the symptoms of the patient. However, measurement of symptomatic outcome is difficult because it is as the patient perceives it to be and not "objective." This creates a need to develop a simple and understandable instrument to measure symptomatic outcome. All patients referred for evaluation of GERD were eligible for this prospective study. During the initial visit, patients were asked to complete the Gastroesophageal Reflux Data Sheet. This ten-item questionnaire included an overall assessment of satisfaction; the best possible score was 0, and the worst was 45. The evaluation included history, physical examination, and additional studies, including upper gastrointestinal series, esophagogastroduodenoscopy, esophageal manometry, and 24-hour esophageal pH monitoring as indicated. Initial treatment was medical with histamine2-blockers, omeprazole, cisapride, or both. If a patient was dissatisfied with medical treatment and had both a hypotensive lower esophageal sphincter and abnormal results of the 24-hour pH monitoring, then operative treatment with either laparoscopic or open Nissen or Toupet fundoplication was offered. After approximately three months of medical treatment or one month after operative treatment, patients were asked to complete the questionnaire again. Data were analyzed using nonparametric tests and linear regression analysis. A total of 72 patients were assessed, and 100 percent of them completed the questionnaire. Patients who were satisfied with their condition had a median health-related quality of life (HRQL) score of five, and those who were dissatisfied had a median score of 26 (p < 0.000001). Patients who ultimately chose surgical therapy had a median preoperative score of 28, compared with 15 for patients who chose to continue medical therapy (p = 0.0001). The change in HRQL score from before treatment to after treatment for surgical patients was 27 compared with 11 for medically treated patients (p < 0.002). Items 1 through 6 of the questionnaire were individually sensitive to the effects of treatment. However, there was no correlation between HRQL and the composite pH score or with the lower esophageal sphincter pressure. This HRQL score has advantages over standard health status instruments for GERD including simplicity for patients (and therefore a high compliance rate), ease of understanding for physicians, and sensitivity to the effects of treatment. In addition, it may help determine, early in the course of treatment, patients who may ultimately require surgical therapy, thereby avoiding prolonged, but futile, medical therapy.
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                Author and article information

                Contributors
                doctortrad@aol.com
                Journal
                Surg Endosc
                Surgical Endoscopy
                Springer-Verlag (New York )
                0930-2794
                1432-2218
                30 September 2011
                30 September 2011
                March 2012
                : 26
                : 3
                : 650-660
                Affiliations
                [1 ]Reston Surgical Associates, 1800 Town Center Dr. # 312, Reston, VA 20190 USA
                [2 ]EndoGastric Solutions, Inc, Redmond, WA USA
                Article
                1932
                10.1007/s00464-011-1932-6
                3271216
                21959689
                878366f9-2dd5-418c-8047-e4ec8a42f0e8
                © The Author(s) 2011
                History
                : 24 March 2011
                : 31 August 2011
                Categories
                Article
                Custom metadata
                © Springer Science+Business Media, LLC 2012

                Surgery
                esophyx,hoarseness,gastroesophageal reflux,tif-2,heartburn,refractory symptoms
                Surgery
                esophyx, hoarseness, gastroesophageal reflux, tif-2, heartburn, refractory symptoms

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