Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial

被引:5
作者
Slagter, Nienke [1 ,2 ]
de Heide, Loek J. M. [1 ]
Jutte, Ewoud H. [1 ]
Kaijser, Mirjam A. [1 ]
Damen, Stefan L. [1 ]
van Beek, Andre P. [3 ]
Emous, Marloes [1 ]
机构
[1] Med Ctr Leeuwarden, Ctr Obes Northern Netherlands CON, Henri Dunantweg 2, NL-8934 AD Leeuwarden, Netherlands
[2] Univ Groningen, Univ Med Ctr Groningen, Groningen, Netherlands
[3] Univ Groningen, Univ Med Ctr Groningen, Dept Endocrinol, Groningen, Netherlands
关键词
Bariatric surgery; One anastomosis gastric bypass; Biliopancreatic limb; Tailoring limb length; Total small bowel length; MORBID-OBESITY; IMPACT; EXPERIENCE; 6-YEAR;
D O I
10.1186/s13063-022-06456-w
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Background: The one anastomosis gastric bypass (OAGB) is being performed by an increasing number of bariatric centers over the world. However, the optimal length of the biliopancreatic (BP) limb remains a topic of discussion. Retrospective studies suggest the benefit of tailoring BP-limb length; however, randomized trials are lacking. The aim of this study is to investigate whether tailoring the length of the BP-limb based on total small bowel length (TSBL) leads to better results in terms of weight loss, vitamin deficiencies, and bowel movements compared to a fixed BP-limb length. Methods: The TAILOR study is a double-blind single-center randomized controlled trial. Patients scheduled for primary OAGB surgery will be randomly allocated either to a standard BP-limb of 150 cm or to a BP-limb length based on their TSBL: TSBL < 500 cm, BP-limb 150 cm; TSBL 500-700 cm, BP-limb 180 cm; TSBL > 700 cm, BP-limb 210 cm. The primary outcome is to compare the percent total weight loss (%TWL) at 5 years between the two groups. Secondary outcomes include nutritional deficiencies, remission of comorbidities, symptoms of dumping, quality of life, and daily bowel movements. The study includes a total of 212 patients and is designed to detect a 5% difference in the primary endpoint. Discussion: The TAILOR study will provide new insights into the effect of different BP-limb lengths and the role of the TSBL in the OAGB. The study is designed to provide guidance for bariatric surgeons to determine the optimal BP-limb length in the OAGB.
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页数:8
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