*General and Endocrine Surgery, Lille University Hospital, Lille, France†Bariatric and Visceral Surgery, Clinique de la Sauvegarde, Lyon, France‡Endocrine and Metabolic Surgery, Marseille University Hospital, France§Bariatric and Visceral Surgery, Clinique de Saint-Omer, Saint-Omer, France¶Bariatric and Visceral Surgery, Arras Hospital, Arras, France||Bariatric and Visceral Surgery, Douai Hospital, Douai, France**Bariatric and Visceral Surgery, Boulogne-sur-Mer Hospital, Boulogne-sur-Mer, France††Bariatric and Visceral Surgery, Clinique de la Victoire, Tourcoing, France‡‡Bariatric and Visceral Surgery, Clinique de la Louvière, Lille, France§§Bariatric and Visceral Surgery, Valenciennes Hospital, Valenciennes, France¶¶Inserm U 1190, European Genomic Institute for Diabetes, Lille University, Lille, France||||Department of biostatistics, Lille University Hospital, Lille, France***King Abdulaziz University Hospital, Jeddah, Saudi Arabia.
Ann Surg. 2016 Nov;264(5):738-744. doi: 10.1097/SLA.0000000000001835.
The aim of the study was to explore the impact of the absence of band fixation on the reoperation rate and to identify other risk factors for long-term complications.
Laparoscopic adjustable gastric banding has been demonstrated to permit important weight loss and comorbidity improvement, but some bands will have to be removed mainly for failure or in case of planned 2-step surgery. Then, the absence of a gastro-gastric suture (GGS) would allow easier band removal. There are insufficient data to conclude that GGS should be abandoned, as the associated risk of band slippage has not been prospectively assessed.
The ANOSEAN study was a randomized controlled single-blind trial (CPP 2009-A00346-51). Primary outcome was reintervention rate for band removal or repositioning at 3 years. It included 706 patients in 17 bariatric centers. Patients in group 1 received a gastric band with GGS. Inclusion criteria were adapted from National Institutes of Health recommendations. Surgical technique was standardized among all surgeons.
At 3 years, the reintervention rate for band retrieval or repositioning was significantly higher in the absence of band fixation (19.4% vs11.3%; P = 0.013), partly because of the slippage rate (10.3% vs 3.6%; P = 0.005). Body mass index <40 kg/m at baseline was also an independent risk factor of slippage (odds ratio 2.769, 95% confidence interval 1.373, 5.581).
GGS prevents band slippage and lower reintervention rate at 3 years. Fixation could be discussed for patients with high BMI who are scheduled to undergo 2-step surgery, but it needs to be specifically assessed.
本研究旨在探讨胃 bands 无固定对再次手术率的影响，并确定其他长期并发症的风险因素。
腹腔镜可调胃束带术已被证明可显著减轻体重并改善合并症，但由于失败或计划进行两步手术，一些 bands 必须被移除。然后，缺乏胃-胃缝合（GGS）将允许更容易地移除 bands。目前还没有足够的数据得出 GGS 应该被放弃的结论，因为尚未前瞻性评估与 bands 滑脱相关的风险。
ANOSEAN 研究是一项随机对照单盲试验（CPP 2009-A00346-51）。主要结局是 3 年时因 bands 移除或重新定位而进行的再次干预率。该研究纳入了 17 个减肥中心的 706 名患者。组 1 的患者接受了带 GGS 的胃 bands。纳入标准是根据美国国立卫生研究院的建议进行调整的。所有外科医生都采用了标准化的手术技术。
3 年时，无 bands 固定组的 bands 取出或重新定位的再次干预率明显更高（19.4%比 11.3%；P = 0.013），部分原因是滑脱率较高（10.3%比 3.6%；P = 0.005）。基线时 BMI <40 kg/m2 也是滑脱的独立风险因素（比值比 2.769，95%置信区间 1.373，5.581）。
GGS 可预防 bands 滑脱和 3 年后的再次干预率升高。对于计划进行两步手术且 BMI 较高的患者，可以讨论固定 bands，但需要进行具体评估。
