PMID- 25448925
OWN - NLM
STAT- MEDLINE
DCOM- 20150324
LR  - 20220331
IS  - 1528-0012 (Electronic)
IS  - 0016-5085 (Linking)
VI  - 148
IP  - 2
DP  - 2015 Feb
TI  - Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation 
      in a randomized controlled trial.
PG  - 324-333.e5
LID - S0016-5085(14)01208-6 [pii]
LID - 10.1053/j.gastro.2014.10.009 [doi]
AB  - BACKGROUND & AIMS: Transoral esophagogastric fundoplication (TF) can decrease or 
      eliminate features of gastroesophageal reflux disease (GERD) in some patients 
      whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed 
      a prospective, sham-controlled trial to determine if TF reduced troublesome 
      regurgitation to a greater extent than PPIs in patients with GERD. METHODS: We 
      screened 696 patients with troublesome regurgitation despite daily PPI use with 3 
      validated GERD-specific symptom scales, on and off PPIs. Those with at least 
      troublesome regurgitation (based on the Montreal definition) on PPIs underwent 
      barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off 
      PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and 
      hiatal hernias </=2 cm were randomly assigned to groups that underwent TF and then 
      received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or 
      twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy 
      during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, 
      patients underwent 48-hour esophageal pH monitoring and 
      esophagogastroduodenoscopy. RESULTS: By intention-to-treat analysis, TF 
      eliminated troublesome regurgitation in a larger proportion of patients (67%) 
      than PPIs (45%) (P = .023). A larger proportion of controls had no response at 3 
      months (36%) than subjects that received TF (11%; P = .004). Control of 
      esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but 
      not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both 
      groups who completed the protocol had similar reductions in GERD symptom scores. 
      Severe complications were rare (3 subjects receiving TF and 1 receiving the sham 
      surgery). CONCLUSIONS: TF was an effective treatment for patients with GERD 
      symptoms, particularly in those with persistent regurgitation despite PPI 
      therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: 
      NCT01136980.
CI  - Copyright (c) 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.
FAU - Hunter, John G
AU  - Hunter JG
AD  - Department of Surgery, Oregon Health & Science University, Portland, Oregon. 
      Electronic address: hunterj@ohsu.edu.
FAU - Kahrilas, Peter J
AU  - Kahrilas PJ
AD  - Department of Surgery and Department of Gastroenterology, Northwestern 
      University, Chicago, Illinois.
FAU - Bell, Reginald C W
AU  - Bell RC
AD  - SurgOne Foregut Institute, Englewood, Colorado.
FAU - Wilson, Erik B
AU  - Wilson EB
AD  - Department of Surgery, University of Texas Health Science Center, Houston, Texas.
FAU - Trad, Karim S
AU  - Trad KS
AD  - Department of Surgery, The George Washington University School of Medicine and 
      Health Sciences, Washington, District of Columbia; Reston Surgical Associates, 
      Reston, Virginia.
FAU - Dolan, James P
AU  - Dolan JP
AD  - Department of Surgery, Oregon Health & Science University, Portland, Oregon.
FAU - Perry, Kyle A
AU  - Perry KA
AD  - Department of Surgery, The Ohio State University, Columbus, Ohio.
FAU - Oelschlager, Brant K
AU  - Oelschlager BK
AD  - Department of Surgery, University of Washington, Seattle, Washington.
FAU - Soper, Nathaniel J
AU  - Soper NJ
AD  - Department of Surgery and Department of Gastroenterology, Northwestern 
      University, Chicago, Illinois.
FAU - Snyder, Brad E
AU  - Snyder BE
AD  - Department of Surgery, University of Texas Health Science Center, Houston, Texas.
FAU - Burch, Miguel A
AU  - Burch MA
AD  - Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California.
FAU - Melvin, William Scott
AU  - Melvin WS
AD  - Department of Surgery, The Ohio State University, Columbus, Ohio.
FAU - Reavis, Kevin M
AU  - Reavis KM
AD  - Department of Surgery, Oregon Health & Science University, Portland, Oregon; 
      Department of Surgery, Oregon Clinic, Portland, Oregon.
FAU - Turgeon, Daniel G
AU  - Turgeon DG
AD  - Department of Surgery, The George Washington University School of Medicine and 
      Health Sciences, Washington, District of Columbia; Reston Surgical Associates, 
      Reston, Virginia.
FAU - Hungness, Eric S
AU  - Hungness ES
AD  - Department of Surgery and Department of Gastroenterology, Northwestern 
      University, Chicago, Illinois.
FAU - Diggs, Brian S
AU  - Diggs BS
AD  - Department of Surgery, Oregon Health & Science University, Portland, Oregon.
LA  - eng
SI  - ClinicalTrials.gov/NCT01136980
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20141013
PL  - United States
TA  - Gastroenterology
JT  - Gastroenterology
JID - 0374630
RN  - 0 (Proton Pump Inhibitors)
RN  - KG60484QX9 (Omeprazole)
SB  - IM
CIN - Gastroenterology. 2015 Feb;148(2):280-2. PMID: 25527969
MH  - Adult
MH  - Aged
MH  - Female
MH  - Fundoplication/*methods
MH  - Gastroesophageal Reflux/*therapy
MH  - Humans
MH  - Hydrogen-Ion Concentration
MH  - Male
MH  - Middle Aged
MH  - Omeprazole/*therapeutic use
MH  - Postoperative Care
MH  - Proton Pump Inhibitors/*therapeutic use
OTO - NOTNLM
OT  - Esophagus
OT  - EsophyX
OT  - Stomach
OT  - TIF
EDAT- 2014/12/03 06:00
MHDA- 2015/03/25 06:00
CRDT- 2014/12/03 06:00
PHST- 2014/07/16 00:00 [received]
PHST- 2014/10/06 00:00 [revised]
PHST- 2014/10/07 00:00 [accepted]
PHST- 2014/12/03 06:00 [entrez]
PHST- 2014/12/03 06:00 [pubmed]
PHST- 2015/03/25 06:00 [medline]
AID - S0016-5085(14)01208-6 [pii]
AID - 10.1053/j.gastro.2014.10.009 [doi]
PST - ppublish
SO  - Gastroenterology. 2015 Feb;148(2):324-333.e5. doi: 10.1053/j.gastro.2014.10.009. 
      Epub 2014 Oct 13.