Gadiot Ralph P M, Grotenhuis Brechtje A, Biter L Ulas, Dunkelgrun Martin, Zengerink Hans J J, Feskens Pierre B G M, Mannaerts Guido H H
Department of Surgery, Sint Franciscus Gasthuis, Rotterdam, The Netherlands.
Department of Surgery, Erasmus MC, Rotterdam, The Netherlands.
BMC Obes. 2015 Jul 15;2:28. doi: 10.1186/s40608-015-0059-z. eCollection 2015.
Morbid obesity has become one of the most frequent chronic medical disorders in Western countries, affecting 1.5-2 % of the Dutch population. Currently, the laparoscopic Roux-Y gastric bypass is considered to be the most effective bariatric treatment option for morbid obesity as it results in adequate weight loss and a significant decrease in comorbidity. Although this technique has been applied for years, the optimal lengths of the three bowel limbs (alimentary limb, biliopancreatic limb, and common channel) in order to achieve maximal percentage excess weight loss with minimal side effects (i.e. malabsorption symptoms), are unknown. As 'normal' sized gastric bypasses achieve an average of 60 - 80 % excess weight loss after one year, one could hypothesize that afferent limb lengths should be longer in order to reduce the common channel length, thereby improving outcome in terms of excess weight loss. The aim of the current study is to investigate the effect of the length of the common channel in gastric bypass surgery for morbid obesity. In this randomized controlled trial the very long Roux limb gastric bypass will be compared to the standard gastric bypass, in order to conclude which option is the optimal therapeutic strategy in the morbidly obese patient.
METHODS/DESIGN: In this multicentre trial patients will be randomized either to a very long Roux limb gastric bypass with a fixed common channel length of 100 cm, or to a standard gastric bypass with a variable common channel length. The primary objective is to evaluate whether the very long Roux limb gastric bypass is superior in terms of percentage excess weight loss after one year follow-up compared to the standard gastric bypass. Secondary endpoints are quality-of-life, cure /improvement of obesity related comorbidity, complications, malnutrition, re-admission rate, and re-operation rate.
We hypothesize that our proposed distal LRYGB will provide for improved results concerning % EWL with an acceptable rate of (metabolic) complications. Our main point of interest is to determine if the distal LRYGB is a superior alternative to standard LRYGB in terms of percentage excess weight loss and to put more focus on the role of the common channel. Therefore we will perform this randomized controlled trial comparing both techniques, with % EWL as a primary outcome.
CCMO registration number: NL43951.101.13 and Netherlands Trial Registry number: NTR4466.
病态肥胖已成为西方国家最常见的慢性疾病之一，影响着1.5%-2%的荷兰人口。目前，腹腔镜Roux-Y胃旁路手术被认为是治疗病态肥胖最有效的减肥方法，因为它能实现充分的体重减轻并显著降低合并症。尽管这项技术已应用多年，但为了在副作用（即吸收不良症状）最小的情况下实现最大程度的超重减轻，三个肠袢（ alimentary limb、biliopancreatic limb和common channel）的最佳长度尚不清楚。由于“正常”大小的胃旁路手术在一年后平均可实现60%-80%的超重减轻，因此可以推测传入袢的长度应该更长，以缩短共同通道的长度，从而在超重减轻方面改善手术效果。本研究的目的是探讨共同通道长度在病态肥胖胃旁路手术中的作用。在这项随机对照试验中，将极长Roux袢胃旁路手术与标准胃旁路手术进行比较，以确定哪种方案是病态肥胖患者的最佳治疗策略。
方法/设计：在这项多中心试验中，患者将被随机分配接受共同通道长度固定为100cm的极长Roux袢胃旁路手术，或接受共同通道长度可变的标准胃旁路手术。主要目的是评估在一年随访后，极长Roux袢胃旁路手术在超重减轻百分比方面是否优于标准胃旁路手术。次要终点包括生活质量、肥胖相关合并症的治愈/改善情况、并发症、营养不良、再入院率和再次手术率。
我们假设我们提出的远端LRYGB在EWL%方面将提供更好的结果，且（代谢）并发症发生率可接受。我们主要关注的是确定远端LRYGB在超重减轻百分比方面是否是标准LRYGB的更好替代方案，并更多地关注共同通道的作用。因此，我们将进行这项随机对照试验，比较这两种技术，以EWL%作为主要结果。
CCMO注册号：NL43951.101.13，荷兰试验注册号：NTR4466。
