Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial
Abstract 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 len...
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| Format: | Article |
| Language: | English |
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BMC
2022-06-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06456-w |
| _version_ | 1811230005172109312 |
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| author | Nienke Slagter Loek J. M. de Heide Ewoud H. Jutte Mirjam A. Kaijser Stefan L. Damen André P. van Beek Marloes Emous |
| author_facet | Nienke Slagter Loek J. M. de Heide Ewoud H. Jutte Mirjam A. Kaijser Stefan L. Damen André P. van Beek Marloes Emous |
| author_sort | Nienke Slagter |
| collection | DOAJ |
| description | Abstract 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 ) |
| first_indexed | 2024-04-12T10:21:35Z |
| format | Article |
| id | doaj.art-85c297d7b24e4404b30a20abd97380ba |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T10:21:35Z |
| publishDate | 2022-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-85c297d7b24e4404b30a20abd97380ba2022-12-22T03:37:04ZengBMCTrials1745-62152022-06-012311810.1186/s13063-022-06456-wTailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trialNienke Slagter0Loek J. M. de Heide1Ewoud H. Jutte2Mirjam A. Kaijser3Stefan L. Damen4André P. van Beek5Marloes Emous6Center for Obesity Northern Netherlands (CON), Medical Center LeeuwardenCenter for Obesity Northern Netherlands (CON), Medical Center LeeuwardenCenter for Obesity Northern Netherlands (CON), Medical Center LeeuwardenCenter for Obesity Northern Netherlands (CON), Medical Center LeeuwardenCenter for Obesity Northern Netherlands (CON), Medical Center LeeuwardenDepartment of Endocrinology, University of Groningen, University Medical Center GroningenCenter for Obesity Northern Netherlands (CON), Medical Center LeeuwardenAbstract 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 )https://doi.org/10.1186/s13063-022-06456-wBariatric surgeryOne anastomosis gastric bypassBiliopancreatic limbTailoring limb lengthTotal small bowel length |
| spellingShingle | Nienke Slagter Loek J. M. de Heide Ewoud H. Jutte Mirjam A. Kaijser Stefan L. Damen André P. van Beek Marloes Emous Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial Trials Bariatric surgery One anastomosis gastric bypass Biliopancreatic limb Tailoring limb length Total small bowel length |
| 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 | Bariatric surgery One anastomosis gastric bypass Biliopancreatic limb Tailoring limb length Total small bowel length |
| url | https://doi.org/10.1186/s13063-022-06456-w |
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