PMID- 17973163
OWN - NLM
STAT- MEDLINE
DCOM- 20080430
LR  - 20211020
IS  - 1432-2218 (Electronic)
IS  - 0930-2794 (Linking)
VI  - 22
IP  - 3
DP  - 2008 Mar
TI  - Safety, feasibility and weight loss after transoral gastroplasty: First human 
      multicenter study.
PG  - 589-98
AB  - OBJECTIVE: To evaluate the safety and feasibility in human subjects of a new 
      transoral restrictive procedure for the treatment of obesity. METHODS: The 
      protocol was approved by the institutional review boards (IRBs) of both centers 
      involved, and all patients gave informed consent. Patients met established 
      inclusion criteria for bariatric surgery. The TOGa system (Satiety Inc., Palo 
      Alto, CA), a set of transoral endoscopically guided staplers, was used to create 
      a stapled restrictive pouch along the lesser curve of the stomach. Patients were 
      hospitalized overnight for observation and underwent barium upper 
      gastrointestinal (UGI) the next morning. Post procedure, all patients were placed 
      on a liquid diet for 1 month and asked to begin an exercise program. Follow-up 
      was carried out at 1 week and 1, 3, 4, 5, and 6 months. RESULTS: Twenty one 
      patients were enrolled [17 female, age 43.7 (22-57) years, BMI 43.3 (35-53) 
      kg/m(2)]. Device introduction was completed safely in all patients. There were no 
      serious adverse events (AEs). The most commonly reported procedure or device 
      related adverse events were vomiting, pain, nausea, and transient dysphagia. At 6 
      month endoscopy, all patients had persistent full or partial stapled sleeves. 
      Gaps in the staple line were evident in 13 patients. Patients lost an average 
      17.6 pounds at 1 month, 24.5 pounds at three months, and 26.5 pounds at 6 months 
      post-treatment [excess weight loss (EWL) of 16.2%, 22.6%, and 24.4%, 
      respectively]. CONCLUSIONS: There is great interest in new procedures for morbid 
      obesity that could offer lower morbidity than current options. Early experience 
      with the TOGa procedure indicates that this transoral approach may be safe and 
      feasible. Further experience with the device and technique should improve 
      anatomic and functional outcomes in the future. Additional studies are underway.
FAU - Deviere, J
AU  - Deviere J
AD  - Department of Gastroenterology and Hepatopancreatology, ULB, Hopital Erasme, 
      Route de Lennik 808, B-1070, Brussels, Belgium. jdeviere@ulb.ac.be
FAU - Ojeda Valdes, G
AU  - Ojeda Valdes G
FAU - Cuevas Herrera, L
AU  - Cuevas Herrera L
FAU - Closset, J
AU  - Closset J
FAU - Le Moine, O
AU  - Le Moine O
FAU - Eisendrath, P
AU  - Eisendrath P
FAU - Moreno, C
AU  - Moreno C
FAU - Dugardeyn, S
AU  - Dugardeyn S
FAU - Barea, M
AU  - Barea M
FAU - de la Torre, R
AU  - de la Torre R
FAU - Edmundowicz, S
AU  - Edmundowicz S
FAU - Scott, S
AU  - Scott S
LA  - eng
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20071101
PL  - Germany
TA  - Surg Endosc
JT  - Surgical endoscopy
JID - 8806653
SB  - IM
EIN - Surg Endosc. 2008 Mar;22(3):599
MH  - Adult
MH  - Body Mass Index
MH  - Endoscopy/adverse effects/methods
MH  - Feasibility Studies
MH  - Female
MH  - Follow-Up Studies
MH  - Gastroplasty/*methods
MH  - Gastroscopy/adverse effects/*methods
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Minimally Invasive Surgical Procedures/methods
MH  - Obesity, Morbid/diagnosis/*surgery
MH  - Postoperative Complications/physiopathology
MH  - Prospective Studies
MH  - *Quality of Life
MH  - Risk Assessment
MH  - Safety Management
MH  - Single-Blind Method
MH  - Treatment Outcome
MH  - Weight Loss
EDAT- 2007/11/02 09:00
MHDA- 2008/05/01 09:00
CRDT- 2007/11/02 09:00
PHST- 2007/04/20 00:00 [received]
PHST- 2007/10/09 00:00 [accepted]
PHST- 2007/10/04 00:00 [revised]
PHST- 2007/11/02 09:00 [pubmed]
PHST- 2008/05/01 09:00 [medline]
PHST- 2007/11/02 09:00 [entrez]
AID - 10.1007/s00464-007-9662-5 [doi]
PST - ppublish
SO  - Surg Endosc. 2008 Mar;22(3):589-98. doi: 10.1007/s00464-007-9662-5. Epub 2007 Nov 
      1.