Patricio Cal1, Luciano Deluca2, Tomás Jakob2, Ezequiel Fernández2. 1. Centro de Rehabilitación Quirúrgica de la Obesidad, Riobamba 429, 8º 806, CP1025, Buenos Aires, Argentina. cal.churruca@gmail.com. 2. Centro de Rehabilitación Quirúrgica de la Obesidad, Riobamba 429, 8º 806, CP1025, Buenos Aires, Argentina.
Abstract
BACKGROUND:Laparoscopic sleeve gastrectomy (LSG) has become a widely used primary bariatric surgery. As this is a restrictive procedure, calibrating bougie size is assumed to impact on 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. MATERIALS AND METHODS: A randomized controlled trial: 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 40-50 kg/m(2), aged 20-70 and absence of prior gastric surgery. All surgeries were performed by the same surgeon. Sample size was calculated to detect a six-point difference in percentage of excess weight loss (%EWL) at 1 year after surgery, considering an α error = 0.05 and a β error = 0.2. The volume of resected stomach, morbidity and weight loss at 6 months and at 1 year after surgery were analyzed. RESULTS: Groups (group A n = 62, group B n = 64) were similar in BMI (44.3 vs. 43.5), aged (41.9 vs. 42.2) and female percentage (87.1 vs. 84.3 %). A 1-year follow-up was achieved in 90.1 and 87.1 %, respectively. Two major complications occurred, one leak in each group (1.6 %). The volume of resected stomach was similar (426 vs. 402 ml, P = 0.71), as well as 6 months %EWL (66.3 vs. 66.6 %; P = 0.91) and 1 year %EWL (75.6 vs. 71.3 %, P = 0.21). A 1-year %EWL higher than 50 was achieved in 96.5 % of patients in group A versus 85.2 % in group B (P = 0.11). CONCLUSIONS: The use of different bougie diameters had no impact on the volume of resected stomach, morbidity or short-term weight loss after LSG, although a trend was seen toward better weight loss with the smaller bougie. A longer-lasting follow-up will be necessary to further assess differences.
RCT Entities:
BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) has become a widely used primary bariatric surgery. As this is a restrictive procedure, calibrating bougie size is assumed to impact on 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. MATERIALS AND METHODS: A randomized controlled trial: 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 40-50 kg/m(2), aged 20-70 and absence of prior gastric surgery. All surgeries were performed by the same surgeon. Sample size was calculated to detect a six-point difference in percentage of excess weight loss (%EWL) at 1 year after surgery, considering an α error = 0.05 and a β error = 0.2. The volume of resected stomach, morbidity and weight loss at 6 months and at 1 year after surgery were analyzed. RESULTS: Groups (group A n = 62, group B n = 64) were similar in BMI (44.3 vs. 43.5), aged (41.9 vs. 42.2) and female percentage (87.1 vs. 84.3 %). A 1-year follow-up was achieved in 90.1 and 87.1 %, respectively. Two major complications occurred, one leak in each group (1.6 %). The volume of resected stomach was similar (426 vs. 402 ml, P = 0.71), as well as 6 months %EWL (66.3 vs. 66.6 %; P = 0.91) and 1 year %EWL (75.6 vs. 71.3 %, P = 0.21). A 1-year %EWL higher than 50 was achieved in 96.5 % of patients in group A versus 85.2 % in group B (P = 0.11). CONCLUSIONS: The use of different bougie diameters had no impact on the volume of resected stomach, morbidity or short-term weight loss after LSG, although a trend was seen toward better weight loss with the smaller bougie. A longer-lasting follow-up will be necessary to further assess differences.
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