PMID- 18814008
OWN - NLM
STAT- MEDLINE
DCOM- 20090423
LR  - 20181113
IS  - 1432-2218 (Electronic)
IS  - 0930-2794 (Linking)
VI  - 23
IP  - 2
DP  - 2009 Feb
TI  - The Plicator procedure for the treatment of gastroesophageal reflux disease: a 
      registry study.
PG  - 423-31
LID - 10.1007/s00464-008-0109-4 [doi]
AB  - BACKGROUND: Endoscopic full-thickness plication of the gastric cardia using the 
      Plicator is shown to be effective for the treatment of symptomatic 
      gastroesophageal reflux disease (GERD) in both prospective and randomized 
      controlled trials. This registry study aimed to evaluate Plicator procedure 
      safety and efficacy among GERD patients treated in routine clinical practice at 
      multiple academic and nonacademic centers. METHODS: An open-label, prospective 
      multicenter trial was conducted at seven centers under institutional review board 
      approval. Patients with symptomatic GERD completed a series of questionnaires at 
      baseline to assess GERD symptoms, heartburn/regurgitation scores, antisecretory 
      medication use, and treatment satisfaction. All the patients then underwent the 
      Plicator procedure with placement of a single transmural pledgeted suture in the 
      anterior gastric cardia. The patients were reevaluated at 12 months after 
      plication. RESULTS: The 12-month follow-up assessment was completed by 81 
      patients. At 12 months, the mean GERD Health-Related Quality-of-Life score had 
      improved significantly compared with the baseline score (12.0 vs 26.6; p < 
      0.001), with 66% of the subjects showing an GERD-HRQL score improved 50% or more. 
      Statistically significant improvements also were observed in median heartburn and 
      regurgitation symptom scores. At 12 months, the need for daily proton pump 
      inhibitor (PPI) therapy was eliminated for 58% of the patients. At baseline, 18% 
      of the subjects had been satisfied with their GERD symptom control while on 
      antisecretory therapy. At 12 months, 75% of the patients were satisfied with 
      their GERD symptom control after undergoing the Plicator procedure, and 86% would 
      recommend the procedure to family or friends. There were no serious adverse 
      events and no late onset of any adverse events. CONCLUSIONS: In this multicenter 
      study, the Plicator procedure effectively improved GERD quality-of-life scores, 
      reduced GERD symptoms and medication use, and yielded higher treatment 
      satisfaction than with the use of chronic antisecretory therapy. These effects 
      all were seen 12 months after plication, and no major adverse effects were 
      observed.
FAU - Birk, John
AU  - Birk J
AD  - Stony Brook University Medical Center, Stony Brook, NY, USA. birk@uchc.edu
FAU - Pruitt, Ronald
AU  - Pruitt R
FAU - Haber, Gregory
AU  - Haber G
FAU - Raijman, Isaac
AU  - Raijman I
FAU - Baluyut, Arthur
AU  - Baluyut A
FAU - Meiselman, Mick
AU  - Meiselman M
FAU - Sedghi, Shahriar
AU  - Sedghi S
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20080924
PL  - Germany
TA  - Surg Endosc
JT  - Surgical endoscopy
JID - 8806653
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cohort Studies
MH  - Esophagogastric Junction/*surgery
MH  - Female
MH  - Fundoplication/instrumentation/*methods
MH  - Gastroesophageal Reflux/*surgery
MH  - *Gastroscopy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Product Surveillance, Postmarketing
MH  - Quality of Life
MH  - *Registries
MH  - Suture Techniques
MH  - Treatment Outcome
EDAT- 2008/09/25 09:00
MHDA- 2009/04/25 09:00
CRDT- 2008/09/25 09:00
PHST- 2008/03/14 00:00 [received]
PHST- 2008/07/08 00:00 [accepted]
PHST- 2008/07/02 00:00 [revised]
PHST- 2008/09/25 09:00 [pubmed]
PHST- 2009/04/25 09:00 [medline]
PHST- 2008/09/25 09:00 [entrez]
AID - 10.1007/s00464-008-0109-4 [doi]
PST - ppublish
SO  - Surg Endosc. 2009 Feb;23(2):423-31. doi: 10.1007/s00464-008-0109-4. Epub 2008 Sep 
      24.