Romeijn M M, Leclercq W K G, Luijten A A P M, Janssen L, van Dielen F M H
Obesity Center Máxima, Máxima Medical Center, Department of Surgery, Eindhoven/Veldhoven, the Netherlands.
BMC Surg. 2020 Jun 5;20(1):122. doi: 10.1186/s12893-020-00784-x.
Weight loss outcomes after bariatric surgery are less favorable in super morbidly obese patients (BMI ≥50 kg/m). Non-response, either defined as insufficient weight loss or weight regain after initial successful weight loss, is a matter of serious concern in these patients. The primary banded Roux-en-Y gastric bypass has shown promising results regarding weight loss in the bariatric population. However, up to now, long-term comparative data about the banded and non-banded bypass in superobese patients is lacking. The aim of this study is to assess the added value of the banded Roux-en-Y gastric bypass in superobese patients on long-term weight loss outcomes.
This single center study will evaluate superobese patients who receive a non-banded Roux-en-Y gastric bypass (NB-RYGB) and a banded Roux-en-Y gastric bypass (B-RYGB). Data from the NB-RYGB group will be collected in retrospect, while data from the B-RYGB group will be collected prospectively. When performing a B-RYGB, a 7.0-8.0 cm silastic ring (MiniMizer®) will be placed proximal to the gastrojejunostomy. The main outcomes of this study are weight loss and non-response during a 10 year follow-up period. Secondary outcomes are reduction of obesity related comorbidities and medication, (ring-related) morbidity and mortality, complications, re-operations, patient satisfaction and health-related quality of life. A total of 142 patients will be included in this study.
This study will help establish the clinical utility of the B-RYGB in superobese patients.
NL8093. Registered 15 October 2019 - Retrospectively registered on the Dutch Registry of Clinical trials, www.trialregister.nl.
在超级病态肥胖患者（体重指数≥50kg/m²）中，减肥手术后的体重减轻效果较差。无反应，即定义为减肥不足或初始成功减肥后体重反弹，是这些患者中一个严重关切的问题。原发性带环Roux-en-Y胃旁路手术在减肥人群中已显示出有前景的减肥效果。然而，到目前为止，缺乏关于超级肥胖患者中带环和不带环胃旁路手术的长期对比数据。本研究的目的是评估带环Roux-en-Y胃旁路手术在超级肥胖患者长期体重减轻结果方面的附加价值。
这项单中心研究将评估接受不带环Roux-en-Y胃旁路手术（NB-RYGB）和带环Roux-en-Y胃旁路手术（B-RYGB）的超级肥胖患者。NB-RYGB组的数据将进行回顾性收集，而B-RYGB组的数据将进行前瞻性收集。进行B-RYGB手术时，将在胃空肠吻合口近端放置一个7.0 - 8.0厘米的硅橡胶环（MiniMizer®）。本研究的主要结果是10年随访期内的体重减轻和无反应情况。次要结果包括肥胖相关合并症和药物的减少、（与环相关的）发病率和死亡率、并发症、再次手术、患者满意度以及健康相关生活质量。本研究共纳入142例患者。
本研究将有助于确立B-RYGB在超级肥胖患者中的临床效用。
NL8093。于2019年10月15日注册 - 在荷兰临床试验注册中心www.trialregister.nl上进行回顾性注册。
