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Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial
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; how...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9214974/ https://www.ncbi.nlm.nih.gov/pubmed/35733198 http://dx.doi.org/10.1186/s13063-022-06456-w |
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author | Slagter, Nienke de Heide, Loek J. M. Jutte, Ewoud H. Kaijser, Mirjam A. Damen, Stefan L. van Beek, André P. Emous, Marloes |
author_facet | Slagter, Nienke de Heide, Loek J. M. Jutte, Ewoud H. Kaijser, Mirjam A. Damen, Stefan L. van Beek, André P. Emous, Marloes |
author_sort | Slagter, Nienke |
collection | PubMed |
description | 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. TRIAL REGISTRATION: Dutch Trial Register NL7945. Prospectively registered on 08 September 2019. NTR (trialregister.nl) SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06456-w. |
format | Online Article Text |
id | pubmed-9214974 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-92149742022-06-23 Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial Slagter, Nienke de Heide, Loek J. M. Jutte, Ewoud H. Kaijser, Mirjam A. Damen, Stefan L. van Beek, André P. Emous, Marloes Trials Study Protocol 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. TRIAL REGISTRATION: Dutch Trial Register NL7945. Prospectively registered on 08 September 2019. NTR (trialregister.nl) SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06456-w. BioMed Central 2022-06-22 /pmc/articles/PMC9214974/ /pubmed/35733198 http://dx.doi.org/10.1186/s13063-022-06456-w Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Slagter, Nienke de Heide, Loek J. M. Jutte, Ewoud H. Kaijser, Mirjam A. Damen, Stefan L. van Beek, André P. Emous, Marloes Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial |
title | Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial |
title_full | Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial |
title_fullStr | Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial |
title_full_unstemmed | Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial |
title_short | Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial |
title_sort | tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (tailor study): study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9214974/ https://www.ncbi.nlm.nih.gov/pubmed/35733198 http://dx.doi.org/10.1186/s13063-022-06456-w |
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