PMID- 29405886
OWN - NLM
STAT- MEDLINE
DCOM- 20181002
LR  - 20220331
IS  - 1553-3514 (Electronic)
IS  - 1553-3506 (Print)
IS  - 1553-3506 (Linking)
VI  - 25
IP  - 2
DP  - 2018 Apr
TI  - The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, 
      and Cost-effective.
PG  - 149-157
LID - 10.1177/1553350618755214 [doi]
AB  - BACKGROUND: Questions remain about the therapeutic durability of transoral 
      incisionless fundoplication (TIF). In this study, clinical outcomes were 
      evaluated at 5 years post-TIF 2.0. METHODS: A total of 63 chronic 
      gastroesophageal reflux disease (GERD) sufferers with troublesome symptoms 
      refractory to proton pump inhibitor (PPI) therapy, absent or </=2 cm hiatal hernia, 
      and abnormal esophageal acid exposure were randomized to the TIF group or PPI 
      group. Following the 6-month evaluation, all patients in the PPI group elected 
      for crossover to TIF; therefore, all 63 patients underwent TIF 2.0 with 
      EsophyX(2) device. Primary outcome was elimination of daily troublesome 
      regurgitation and atypical symptoms at the 5-year follow-up. Secondary outcomes 
      were improvement in symptom scores, PPI use, reoperations, and patient health 
      satisfaction. The cost-effectiveness of TIF 2.0 was also estimated. RESULTS: Of 
      63 patients, 60 were available at 1 year, 52 at 3 years, and 44 at 5 years for 
      evaluation. Troublesome regurgitation was eliminated in 88% of patients at 1 
      year, 90% at 3 years, and 86% at 5 years. Resolution of troublesome atypical 
      symptoms was achieved in 82% of patients at 1 year, 88% at 3 years, and 80% at 5 
      years. No serious adverse events occurred. There were 3 reoperations by the end 
      of the 5-year follow-up. At the 5-year follow-up, 34% of patients were on daily 
      PPI therapy as compared with 100% of patients at screening. The total GERD 
      Health-related quality-of-life score improved by decreasing from 22.2 to 6.8 at 5 
      years ( P < .001). CONCLUSION: In this patient population, the TIF 2.0 procedure 
      provided safe and sustained long-term elimination of troublesome GERD symptoms.
FAU - Trad, Karim S
AU  - Trad KS
AD  - 1 The George Washington University School of Medicine and Health Science, 
      Washington, DC, USA.
AD  - 2 The George Washington University Medical Faculty Associates, Washington, DC, 
      USA.
FAU - Barnes, William E
AU  - Barnes WE
AD  - 3 Livingston Hospital and Healthcare Services, Inc, CAH, Salem, KY, USA.
FAU - Prevou, Elizabeth R
AU  - Prevou ER
AD  - 2 The George Washington University Medical Faculty Associates, Washington, DC, 
      USA.
FAU - Simoni, Gilbert
AU  - Simoni G
AD  - 4 Advanced Gastroenterology, Inc, Thousand Oaks, CA, USA.
FAU - Steffen, Jennifer A
AU  - Steffen JA
AD  - 2 The George Washington University Medical Faculty Associates, Washington, DC, 
      USA.
FAU - Shughoury, Ahmad B
AU  - Shughoury AB
AD  - 5 Saint Mary Medical Center, Hobart, IN, USA.
AD  - 6 Internal Medicine Associates, Merrillville, IN, USA.
FAU - Raza, Mamoon
AU  - Raza M
AD  - 7 Indiana Medical Research, Elkhart, IN, USA.
AD  - 8 Unity Surgical Hospital, Mishawaka, IN, USA.
FAU - Heise, Jeffrey A
AU  - Heise JA
AD  - 9 Hancock Regional Hospital, Greenfield, IN, USA.
FAU - Fox, Mark A
AU  - Fox MA
AD  - 10 Crossville Medical Group, Crossville, TN, USA.
AD  - 11 Cumberland Medical Center, Crossville, TN, USA.
FAU - Mavrelis, Peter G
AU  - Mavrelis PG
AD  - 5 Saint Mary Medical Center, Hobart, IN, USA.
AD  - 6 Internal Medicine Associates, Merrillville, IN, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20180206
PL  - United States
TA  - Surg Innov
JT  - Surgical innovation
JID - 101233809
RN  - 0 (Proton Pump Inhibitors)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cost-Benefit Analysis
MH  - Cross-Over Studies
MH  - Female
MH  - *Fundoplication/adverse effects/economics/methods/statistics & numerical data
MH  - Gastroesophageal Reflux/*therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Postoperative Complications
MH  - Proton Pump Inhibitors/therapeutic use
MH  - Reoperation/statistics & numerical data
MH  - Treatment Outcome
PMC - PMC5946656
OTO - NOTNLM
OT  - EsophyX
OT  - atypical GERD symptoms
OT  - heartburn
OT  - proton pump inhibitor (PPI)
OT  - regurgitation
OT  - transoral incisionless fundoplication (TIF)
COIS- Declaration of Conflicting Interests: The author(s) declared the following 
      potential conflicts of interest with respect to the research, authorship, and/or 
      publication of this article: KST, MR, and GS have received speaking honoraria 
      from EndoGastric Solutions. WEB, ABS, PGM, JAH, and MAF have no conflicts of 
      interest or financial ties to disclose. ERP and JAS have no conflicts of interest 
      or financial ties to disclose.
EDAT- 2018/02/07 06:00
MHDA- 2018/10/03 06:00
PMCR- 2018/05/11
CRDT- 2018/02/07 06:00
PHST- 2018/02/07 06:00 [pubmed]
PHST- 2018/10/03 06:00 [medline]
PHST- 2018/02/07 06:00 [entrez]
PHST- 2018/05/11 00:00 [pmc-release]
AID - 10.1177_1553350618755214 [pii]
AID - 10.1177/1553350618755214 [doi]
PST - ppublish
SO  - Surg Innov. 2018 Apr;25(2):149-157. doi: 10.1177/1553350618755214. Epub 2018 Feb 
      6.