Lee L Swanstrom, MD, Andras Legner, MD, Peter Halvax, MD, Aron Altorjay, MD. Intitute Hopitaux Universitaires – Strasbourg, France; St George Hospital, Szekesfehervar, Hungary.
Introduction: An outpatient transoral endoscopic procedure for morbid obesity would be appealing: if safe, effective and durable. Previous endoluminal gastroplasties have had only transient effectiveness due to mucosa to mucosa gastric wall apposition or superficial staple/suture purchase. We present early clinical results for 13 patients undergoing gastroplasties with a novel endoscopic full-thickness suturing device to form a internal restrictive ring just distal to the gastroesophageal junction.
Methods: Thirteen patients with morbid obesity (BMI 35 – 62) were selected according to an IRB approved study protocol. All patients underwent a psychological evaluation, a history and physical examination, blood tests including a lipid profile and A1c level and quality of life and reflux questionnaires. After informed consent and under general anesthesia, an endoscopic procedure was performed. Using a propriatary suction mucosectomy device, two mucosal excisions were created just below the gastro-esophageal junction. A second device was used to perform full thickness suturing of the excision beds for apposition of the anterior and posterior gastric wall. Injection of hypertonic saline on the lesser curvature side was used to decrease fundic compliance.
Results: All patients had a completed procedure although 4 had significant bleeding (150 – 275 cc) from the mucosal excision site. Mean operative time was 161 minutes (82 – 297). There was no post procedure bleeding or need for blood transfusion. No other complications were encountered although one patient required hospitalization 2 weeks after surgery for unrelated viral enteritis and dehydration. Patients were encouraged to eat frequent small protein heavy meals after 2 weeks of a pureed diet. At 3 month follow-up, the average excess weight loss was 26.4% (6% – 36%), 3 of 4 diabetic patients had normalization of their A1c and 2 of 8 patients with pre-procedure hypertension normalized their blood pressure.
Conclusion: For this first human experience with a new endoscopic suturing device we found the procedure and devices to be safe and effective. We report promising early results using the device as an endoluminal treatment for morbid obesity.