Patricio Cal, MD, Tomas Jakob, Luciano Deluca, Ezequiel Fernandez. CRQO
Laparoscopic sleeve gastrectomy (LSG) has become a widely used primary bariatric surgery. Being a restrictive procedure, calibrating bougie size is assumed to impact both morbidity and weight loss. However, no prospective studies have confirmed this hypothesis. The objective of this trial was to compare LSG outcomes using different calibrating bougie diameters.
Methods & Procedures:
Prospective randomized controlled trial. One hundred and twenty six (126) patients undergoing LSG were randomized to either a 27 Fr (group A) or a 39 Fr (group B) calibrating bougie. Inclusion criteria were BMI between 40 and 50 kg/m2, age between 20 and 70 and absence of prior gastric surgery. All surgeries were performed by the same surgeon. Sample size was calculated to detect a 6 point difference in percentage of excess weight loss (%EWL) 1 year after surgery, considering an α error=0.05 and β error =0.2, assuming a standard deviation of 14. Volume of resected stomach, morbidity and weight loss 6 months and 1 year after surgery were analyzed.
Both groups (Group A n=62, Group B n=64) were similar in BMI (44.3 vs 43.5, P=NS), age (41.9 vs 42.2, P=NS) and female percentage (87.1% vs 84.3%, P=NS). We achieved 1 year follow up in 90.1% and 87.1 % respectively. Two major complications occurred, 1 leak in each group. Volume of resected stomach was similar (426 ml vs 402 ml, P=NS), as were %EWL at 6 months (66.3% vs 66.6%) and 1 year after surgery (75.6% vs 71.3%, P=NS). A 1 year %EWL higher than 50 was achieved in 96.5% of patients in group A vs 85.2% in group B (P=NS).
Using different bougie diameter had no impact on volume of resected stomach, morbidity or short term weight loss after LSG. Longer follow up will be necessary to further assess differences.