Oral Ospanov1,2, J N Buchwald3, Galymzhan Yeleuov4, Farida Bekmurzinova4. 1. University Medical Center, Nur-Sultan, Kazakhstan. bariatric.kz@gmail.com. 2. Department of Laparoscopic and Bariatric Surgery, Astana Medical University, Syganak Str. 5/1. K. 48, Nur-Sultan, Kazakhstan. bariatric.kz@gmail.com. 3. Division of Scientific Research Writing, Medwrite Medical Communications, Maiden Rock, WI, USA. 4. University Medical Center, Nur-Sultan, Kazakhstan.
Abstract
BACKGROUND:One-anastomosis gastric bypass with band-separated gastric pouch (OAGB-BSGP) is a novel "staplerless" version of OAGB. This randomized controlled trial (RCT) compared 2-year outcomes for OAGB-BSGP and standard OAGB. METHODS: The parallel-group RCT randomly allocated patients to group A, staplerless OAGB-BSGP, or group B, stapled OAGB. RESULTS: Respective mean values for groups A and B (n = 40 each): baseline body mass index (BMI, kg/m2), 40.6 ± 5.6 vs 41.2 ± 6.4 (p = 0.64); abdominal bleeding (mL), 5.9 ± 8.0 vs 31.1 ± 30.5 (p < 0.0001). Two-year outcomes: BMI, 26.3 ± 3.2 vs 29.0 ± 4.7; %TWL, 34.1 ± 9.0 vs 29.3 ± 10.6, p < 0.03; %EBMIL, 94.3 ± 23.6 vs 77.9 ± 29.3, p < 0.007; bile reflux, n = 1 (2.5%) vs n = 7 (17.5%) (p = 0.05); revisions, n = 0 vs n = 4 (10.0%), p = 0.12. CONCLUSIONS: At 2-year RCT follow-up, staplerless OAGB-BSGP patients had fewer complications, no revisions, and greater weight loss than stapled OAGB patients. TRIAL REGISTRATION: ISRCTN56106651 (OSPAN-RCT).
RCT Entities:
BACKGROUND: One-anastomosis gastric bypass with band-separated gastric pouch (OAGB-BSGP) is a novel "staplerless" version of OAGB. This randomized controlled trial (RCT) compared 2-year outcomes for OAGB-BSGP and standard OAGB. METHODS: The parallel-group RCT randomly allocated patients to group A, staplerless OAGB-BSGP, or group B, stapled OAGB. RESULTS: Respective mean values for groups A and B (n = 40 each): baseline body mass index (BMI, kg/m2), 40.6 ± 5.6 vs 41.2 ± 6.4 (p = 0.64); abdominal bleeding (mL), 5.9 ± 8.0 vs 31.1 ± 30.5 (p < 0.0001). Two-year outcomes: BMI, 26.3 ± 3.2 vs 29.0 ± 4.7; %TWL, 34.1 ± 9.0 vs 29.3 ± 10.6, p < 0.03; %EBMIL, 94.3 ± 23.6 vs 77.9 ± 29.3, p < 0.007; bile reflux, n = 1 (2.5%) vs n = 7 (17.5%) (p = 0.05); revisions, n = 0 vs n = 4 (10.0%), p = 0.12. CONCLUSIONS: At 2-year RCT follow-up, staplerless OAGB-BSGP patients had fewer complications, no revisions, and greater weight loss than stapled OAGB patients. TRIAL REGISTRATION: ISRCTN56106651 (OSPAN-RCT).
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