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Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease.
Am J Gastroenterol 2015; 110(4):531-42AJ

Abstract

OBJECTIVES

Transoral incisionless fundoplication (TIF) was developed in an attempt to create a minimally invasive endoscopic procedure that mimics antireflux surgery. The objective of this trial was to evaluate effectiveness of TIF compared with proton pump inhibition in a population consisting of gastroesophageal reflux disease (GERD) patients controlled with proton pump inhibitors (PPIs) who opted for an endoscopic intervention over lifelong drug dependence.

METHODS

Patients with chronic GERD were randomized (2:1) for TIF or continuation of PPI therapy. American Society of Anesthesiologists >2, body mass index >35 kg/m(2), hiatal hernia >2 cm, and esophageal motility disorders were exclusion criteria. Primary outcome measure was GERD-related quality of life. Secondary outcome measures were esophageal acid exposure, number of reflux episodes, PPI usage, appearance of the gastroesophageal valve, and healing of reflux esophagitis. Crossover for the PPI group was allowed after 6 months.

RESULTS

A total of 60 patients (TIF n=40, PPI n=20, mean body mass index 26 kg/m(2), 37 male) were included. At 6 months, GERD symptoms were more improved in the TIF group compared with the PPI group (P<0.001), with a similar improvement of distal esophageal acid exposure (P=0.228) compared with baseline. The pH normalization for TIF group and PPI group was 50% and 63%, respectively. All patients allocated for PPI treatment opted for crossover. At 12 months, quality of life remained improved after TIF compared with baseline (P<0.05), but no improvement in esophageal acid exposure compared with baseline was found (P=0.171) and normalization of pH was accomplished in only 29% in conjunction with deteriorated valve appearances at endoscopy and resumption of PPIs in 61%.

CONCLUSION

Although TIF resulted in an improved GERD-related quality of life and produced a short-term improvement of the antireflux barrier in a selected group of GERD patients, no long-term objective reflux control was achieved.

Authors+Show Affiliations

1] Department of Surgery, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands [2] Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.Department of Gastroenterology and Hepatology, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.Department of Gastroenterology and Hepatology, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.Department of Clinical Epidemiolgy and Medical Technology Assessment, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.Department of Gastroenterology and Hepatology, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.Department of Surgery, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.Department of Surgery, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25823768

Citation

Witteman, Bart P L., et al. "Randomized Controlled Trial of Transoral Incisionless Fundoplication Vs. Proton Pump Inhibitors for Treatment of Gastroesophageal Reflux Disease." The American Journal of Gastroenterology, vol. 110, no. 4, 2015, pp. 531-42.
Witteman BP, Conchillo JM, Rinsma NF, et al. Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease. Am J Gastroenterol. 2015;110(4):531-42.
Witteman, B. P., Conchillo, J. M., Rinsma, N. F., Betzel, B., Peeters, A., Koek, G. H., ... Bouvy, N. D. (2015). Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease. The American Journal of Gastroenterology, 110(4), pp. 531-42. doi:10.1038/ajg.2015.28.
Witteman BP, et al. Randomized Controlled Trial of Transoral Incisionless Fundoplication Vs. Proton Pump Inhibitors for Treatment of Gastroesophageal Reflux Disease. Am J Gastroenterol. 2015;110(4):531-42. PubMed PMID: 25823768.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease. AU - Witteman,Bart P L, AU - Conchillo,Jose M, AU - Rinsma,Nicolaas F, AU - Betzel,Bark, AU - Peeters,Andrea, AU - Koek,Ger H, AU - Stassen,Laurents P S, AU - Bouvy,Nicole D, Y1 - 2015/03/31/ PY - 2014/03/02/received PY - 2014/12/02/accepted PY - 2015/4/1/entrez PY - 2015/4/1/pubmed PY - 2015/6/16/medline SP - 531 EP - 42 JF - The American journal of gastroenterology JO - Am. J. Gastroenterol. VL - 110 IS - 4 N2 - OBJECTIVES: Transoral incisionless fundoplication (TIF) was developed in an attempt to create a minimally invasive endoscopic procedure that mimics antireflux surgery. The objective of this trial was to evaluate effectiveness of TIF compared with proton pump inhibition in a population consisting of gastroesophageal reflux disease (GERD) patients controlled with proton pump inhibitors (PPIs) who opted for an endoscopic intervention over lifelong drug dependence. METHODS: Patients with chronic GERD were randomized (2:1) for TIF or continuation of PPI therapy. American Society of Anesthesiologists >2, body mass index >35 kg/m(2), hiatal hernia >2 cm, and esophageal motility disorders were exclusion criteria. Primary outcome measure was GERD-related quality of life. Secondary outcome measures were esophageal acid exposure, number of reflux episodes, PPI usage, appearance of the gastroesophageal valve, and healing of reflux esophagitis. Crossover for the PPI group was allowed after 6 months. RESULTS: A total of 60 patients (TIF n=40, PPI n=20, mean body mass index 26 kg/m(2), 37 male) were included. At 6 months, GERD symptoms were more improved in the TIF group compared with the PPI group (P<0.001), with a similar improvement of distal esophageal acid exposure (P=0.228) compared with baseline. The pH normalization for TIF group and PPI group was 50% and 63%, respectively. All patients allocated for PPI treatment opted for crossover. At 12 months, quality of life remained improved after TIF compared with baseline (P<0.05), but no improvement in esophageal acid exposure compared with baseline was found (P=0.171) and normalization of pH was accomplished in only 29% in conjunction with deteriorated valve appearances at endoscopy and resumption of PPIs in 61%. CONCLUSION: Although TIF resulted in an improved GERD-related quality of life and produced a short-term improvement of the antireflux barrier in a selected group of GERD patients, no long-term objective reflux control was achieved. SN - 1572-0241 UR - https://www.unboundmedicine.com/medline/citation/25823768/Randomized_controlled_trial_of_transoral_incisionless_fundoplication_vs__proton_pump_inhibitors_for_treatment_of_gastroesophageal_reflux_disease_ L2 - http://Insights.ovid.com/pubmed?pmid=25823768 DB - PRIME DP - Unbound Medicine ER -