Department of Surgery, Torsby Hospital, Box 502, 685 29, Torsby, Sweden.
Faculty of Health and Medicine, Örebro University, Campus USÖ, 701 82, Örebro, Sweden.
Obes Surg. 2024 Sep;34(9):3382-3389. doi: 10.1007/s11695-024-07421-z. Epub 2024 Jul 23.
This randomized clinical trial evaluated the clinical outcomes of two surgical interventions for obesity treatment: single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI) and biliopancreatic diversion with duodenal switch (BPD/DS). The SADI procedure was developed as a response to the challenges posed by the BPD/DS procedure, aiming to enhance surgical efficiency, minimize postoperative risks, and maintain therapeutic efficacy. The present study primarily focused on early complications and short-term results.
Fifty-six patients with a body mass index (BMI) ranging from 42 to 72 kg/m were randomly assigned to either the SADI or BPD/DS procedure. Parameters compared included % excess weight loss (%EWL), % total weight loss (%TWL), length of hospital stay (LOS), re-admission rates, and complications.
Both groups had similar demographics and baseline characteristics. SADI had a mean operating time of 109 min, significantly shorter than BPD/DS at 139 min (p < 0.001). Early complications occurred in five patients in the SADI group and in four patients in the BPD/DS group with no mortality. Median LOS was 2 days for both SADI and BPD/DS. Within 30 days, one SADI patient and three BPD/DS patients required re-admission. Serious late complications necessitating reoperation were observed in three SADI and two BPD/DS patients. After 1 year, %EWL and %TWL were similar: SADI (81.8% ± 13.6% and 40.1% ± 5.9%) and BPD/DS (84.2% ± 14.0% and 41.6% ± 6.4%).
This trial suggests that both the SADI and BPD/DS yield comparable weight loss outcomes after 1 year, with a notable risk profile.
NCT03938571 ( http://www.
gov ).
本随机临床试验评估了两种肥胖治疗手术干预的临床结果：单吻合口十二指肠空肠旁路加袖状胃切除术（SADI）和胆胰分流加十二指肠转位术（BPD/DS）。SADI 手术是作为对 BPD/DS 手术挑战的回应而开发的，旨在提高手术效率，降低术后风险，并保持治疗效果。本研究主要关注早期并发症和短期结果。
将 56 名 BMI 范围为 42 至 72kg/m²的患者随机分配至 SADI 或 BPD/DS 手术组。比较的参数包括%体重减轻过量（%EWL）、%体重减轻总量（%TWL）、住院时间（LOS）、再入院率和并发症。
两组的人口统计学和基线特征相似。SADI 的平均手术时间为 109 分钟，明显短于 BPD/DS 的 139 分钟（p<0.001）。SADI 组有 5 例和 BPD/DS 组有 4 例患者发生早期并发症，但无死亡。SADI 和 BPD/DS 的中位 LOS 均为 2 天。在 30 天内，1 例 SADI 患者和 3 例 BPD/DS 患者需要再次入院。3 例 SADI 患者和 2 例 BPD/DS 患者发生严重的迟发性并发症需要再次手术。1 年后，%EWL 和 %TWL 相似：SADI（81.8%±13.6%和 40.1%±5.9%）和 BPD/DS（84.2%±14.0%和 41.6%±6.4%）。
本试验表明，SADI 和 BPD/DS 在 1 年后的减重效果相当，但风险特征明显。
NCT03938571（http://www.clinicaltrials.gov）。
NCT03938571（http://www.clinicaltrials.gov）。
