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Evaluation Studies
Journal Article
Research Support, Non-U.S. Gov't
Endocinch therapy for gastro-oesophageal reflux disease: a one year prospective follow up.
Gut 2003 January
BACKGROUND: Gastro-oesophageal reflux disease (GORD) is, in the main, treated with either proton pump inhibitor (PPI) drugs or a Nissen fundoplication operation. Recently, BARD developed Endocinch, a device used to place sutures just below the oesophagogastric junction (OGJ) to treat GORD.
AIM: To evaluate the long term benefit of the Endocinch technique in patients seen up to 12 months post procedure.
PATIENTS: Twenty six patients with symptoms of GORD were recruited and had the procedure performed. Four patients were lost to follow up.
METHODS: Twenty two patients completed their one year follow up. Pre procedure and post procedure (up to 12 months) assessments included symptom scoring (DeMeester), upper intestinal endoscopy, oesophageal manometry and 24 hour oesophageal pH, and completion of quality of life (QOL) questionnaires.
RESULTS: Mean age was 39 years (range 22-62). Heartburn symptom score was reduced from a mean value of 19.22 at baseline to 7.5 at 12 months (n=22) (p<0.0001). Regurgitation score reduced from a mean of 2.27 at baseline to 0.86 at 12 months (n=22) (p<0.001). Mean (SEM) pH DeMeester acid score was reduced from 44.1 (4.3) to 33.32 (4.73) (p=0.028) at three month post procedure. Percentage upright acid exposure and number of reflux episodes were also reduced significantly. Use of PPIs was reduced by 64% at 12 months post procedure. All QOL assessments showed significant improvement (p=0.01). All transient post procedure complaints resolved within 72 hours.
CONCLUSION: The Endocinch procedure is an effective and safe outpatient procedure that offers GORD patients significant improvement in symptomatology, QOL, and reduced requirements for PPIs over at least a one year period.
AIM: To evaluate the long term benefit of the Endocinch technique in patients seen up to 12 months post procedure.
PATIENTS: Twenty six patients with symptoms of GORD were recruited and had the procedure performed. Four patients were lost to follow up.
METHODS: Twenty two patients completed their one year follow up. Pre procedure and post procedure (up to 12 months) assessments included symptom scoring (DeMeester), upper intestinal endoscopy, oesophageal manometry and 24 hour oesophageal pH, and completion of quality of life (QOL) questionnaires.
RESULTS: Mean age was 39 years (range 22-62). Heartburn symptom score was reduced from a mean value of 19.22 at baseline to 7.5 at 12 months (n=22) (p<0.0001). Regurgitation score reduced from a mean of 2.27 at baseline to 0.86 at 12 months (n=22) (p<0.001). Mean (SEM) pH DeMeester acid score was reduced from 44.1 (4.3) to 33.32 (4.73) (p=0.028) at three month post procedure. Percentage upright acid exposure and number of reflux episodes were also reduced significantly. Use of PPIs was reduced by 64% at 12 months post procedure. All QOL assessments showed significant improvement (p=0.01). All transient post procedure complaints resolved within 72 hours.
CONCLUSION: The Endocinch procedure is an effective and safe outpatient procedure that offers GORD patients significant improvement in symptomatology, QOL, and reduced requirements for PPIs over at least a one year period.
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