Dr Devière and colleagues from Belgium evaluated the safety and feasibility in human subjects of a new transoral restrictive procedure for the treatment of obesity.
The protocol was approved by the institutional review boards of both centers involved, and all patients gave informed consent.
Patients met established inclusion criteria for bariatric surgery.
The team used the transoral gastroplasty system, a set of transoral endoscopically guided staplers, to create a stapled restrictive pouch along the lesser curve of the stomach.
|Patients lost an average 18 pounds at 1 month|
|Journal Surgical Endoscopy|
Patients were hospitalized overnight for observation, and underwent barium upper gastrointestinal 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.
The researchers enrolled 21 patients, of which 17 were female aged 22 to 57 years, with a body mass index of 43 kg/m2.
Device introduction was completed safely in all patients.
The team found no serious adverse events.
The most commonly reported procedure or device related adverse events were vomiting, pain, nausea, and transient dysphagia.
The research team found at 6 month endoscopy, that all patients had persistent full or partial stapled sleeves.
Gaps in the staple line were evident in 13 patients.
The team found that patients lost an average 18 pounds at 1 month, 25 pounds at 3 months, and 27 pounds at 6 months post-treatment.
This is equivalent to an excess weight loss of 16%, 23%, and 24%, at 1, 3 and 6 months, respectively.
Dr Devières' team concluded, "There is great interest in new procedures for morbid obesity that could offer lower morbidity than current options."
"Early experience with the transoral gastroplasty 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."