Long-term effect of sleeve gastrectomy vs Roux-en-Y gastric bypass in people living with severe obesity: a phase III multicentre randomised controlled trial (SleeveBypass)
Sleeve gastrectomy is the most performed metabolic surgical procedure worldwide. However, conflicting results offer no clear evidence about its long-term clinical comparability to Roux-en-Y gastric bypass. This study aims to determine their equivalent long-term weight loss effects. This randomised o...
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| Veröffentlicht in: | The Lancet regional health. Europe 2024-03, Vol.38, p.100836-100836, Article 100836 |
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| creator | Biter, L Ulas ‘t Hart, Judith WH Noordman, Bo J. Smulders, J Frans Nienhuijs, Simon Dunkelgrün, Martin Zengerink, Johannes F. Birnie, Erwin Friskes, Irene AM Mannaerts, Guido HH Apers, Jan A. |
| description | Sleeve gastrectomy is the most performed metabolic surgical procedure worldwide. However, conflicting results offer no clear evidence about its long-term clinical comparability to Roux-en-Y gastric bypass. This study aims to determine their equivalent long-term weight loss effects.
This randomised open-label controlled trial was conducted from 2012 until 2017 in two Dutch bariatric hospitals with a 5-year follow-up (last follow-up July 29th, 2022). Out of 4045 patients, 628 were eligible for metabolic surgery and were randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass (intention-to-treat). The primary endpoint was weight loss, expressed by percentage excess body mass index (BMI) loss. The predefined clinically relevant equivalence margin was −13% to 13%. Secondary endpoints included percentage total kilograms weight loss, obesity-related comorbidities, quality of life, morbidity, and mortality. This trial is registered with Dutch Trial Register NTR4741: https://onderzoekmetmensen.nl/nl/trial/25900.
628 patients were randomised between sleeve gastrectomy (n = 312) and Roux-en-Y gastric bypass (n = 316) (mean age 43 [standard deviation (SD), 11] years; mean BMI 43.5 [SD, 4.7]; 81.8% women). Excess BMI loss at 5 years was 58.8% [95% CI, 55%–63%] after sleeve gastrectomy and 67.1% [95% CI, 63%–71%] after Roux-en-Y gastric bypass (difference 8.3% [95% CI, −12.5% to −4.0%]). This was within the predefined margin (P |
| doi_str_mv | 10.1016/j.lanepe.2024.100836 |
| format | Article |
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This randomised open-label controlled trial was conducted from 2012 until 2017 in two Dutch bariatric hospitals with a 5-year follow-up (last follow-up July 29th, 2022). Out of 4045 patients, 628 were eligible for metabolic surgery and were randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass (intention-to-treat). The primary endpoint was weight loss, expressed by percentage excess body mass index (BMI) loss. The predefined clinically relevant equivalence margin was −13% to 13%. Secondary endpoints included percentage total kilograms weight loss, obesity-related comorbidities, quality of life, morbidity, and mortality. This trial is registered with Dutch Trial Register NTR4741: https://onderzoekmetmensen.nl/nl/trial/25900.
628 patients were randomised between sleeve gastrectomy (n = 312) and Roux-en-Y gastric bypass (n = 316) (mean age 43 [standard deviation (SD), 11] years; mean BMI 43.5 [SD, 4.7]; 81.8% women). Excess BMI loss at 5 years was 58.8% [95% CI, 55%–63%] after sleeve gastrectomy and 67.1% [95% CI, 63%–71%] after Roux-en-Y gastric bypass (difference 8.3% [95% CI, −12.5% to −4.0%]). This was within the predefined margin (P < 0.001). Total weight loss at 5 years was 22.5% [95% CI, 20.7%–24.3%] after sleeve gastrectomy and 26.0% [95% CI, 24.3%–27.8%] after Roux-en-Y gastric bypass (difference 3.5% [95% CI, −5.2% to −1.7%]). In both groups, obesity-related comorbidities significantly improved after 5 years. Dyslipidaemia improved more frequently after Roux-en-Y gastric bypass (83%, 54/65) compared to sleeve gastrectomy (62%, 44/71) (P = 0.006). De novo gastro-oesophageal reflux disease occurred more frequently after sleeve gastrectomy (16%, 46/288) vs Roux-en-Y gastric bypass (4%, 10/280) (P < 0.001). Minor complications were more frequent after Roux-en-Y gastric bypass (5%, 15/316) compared to sleeve gastrectomy (2%, 5/312). No statistically significant differences in major complications and health-related quality of life were encountered.
In people living with obesity grades 2 and 3, sleeve gastrectomy and Roux-en-Y gastric bypass had clinically comparable excess BMI loss according to the predefined definition for equivalence. However, Roux-en-Y gastric bypass showed significantly higher total weight loss and significant advantages in secondary outcomes, including dyslipidaemia and GERD, yet at a higher rate of minor complications. Major complications, other comorbidities, and overall HRQoL did not significantly differ between the groups.
Not applicable.</description><identifier>ISSN: 2666-7762</identifier><identifier>EISSN: 2666-7762</identifier><identifier>DOI: 10.1016/j.lanepe.2024.100836</identifier><identifier>PMID: 38313139</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Complications ; GERD ; Long-term follow-up ; Roux-en-Y gastric bypass ; Sleeve gastrectomy ; Weight loss</subject><ispartof>The Lancet regional health. Europe, 2024-03, Vol.38, p.100836-100836, Article 100836</ispartof><rights>2024 The Author(s)</rights><rights>2024 The Author(s).</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c408t-7c3f7961f2aa1196bb9ef55a9dcd7504cf315d74f036c1689ae094cd120a7e513</citedby><cites>FETCH-LOGICAL-c408t-7c3f7961f2aa1196bb9ef55a9dcd7504cf315d74f036c1689ae094cd120a7e513</cites><orcidid>0000-0002-2239-8449</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,778,782,862,27911,27912</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38313139$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Biter, L Ulas</creatorcontrib><creatorcontrib>‘t Hart, Judith WH</creatorcontrib><creatorcontrib>Noordman, Bo J.</creatorcontrib><creatorcontrib>Smulders, J Frans</creatorcontrib><creatorcontrib>Nienhuijs, Simon</creatorcontrib><creatorcontrib>Dunkelgrün, Martin</creatorcontrib><creatorcontrib>Zengerink, Johannes F.</creatorcontrib><creatorcontrib>Birnie, Erwin</creatorcontrib><creatorcontrib>Friskes, Irene AM</creatorcontrib><creatorcontrib>Mannaerts, Guido HH</creatorcontrib><creatorcontrib>Apers, Jan A.</creatorcontrib><title>Long-term effect of sleeve gastrectomy vs Roux-en-Y gastric bypass in people living with severe obesity: a phase III multicentre randomised controlled trial (SleeveBypass)</title><title>The Lancet regional health. Europe</title><addtitle>Lancet Reg Health Eur</addtitle><description>Sleeve gastrectomy is the most performed metabolic surgical procedure worldwide. However, conflicting results offer no clear evidence about its long-term clinical comparability to Roux-en-Y gastric bypass. This study aims to determine their equivalent long-term weight loss effects.
This randomised open-label controlled trial was conducted from 2012 until 2017 in two Dutch bariatric hospitals with a 5-year follow-up (last follow-up July 29th, 2022). Out of 4045 patients, 628 were eligible for metabolic surgery and were randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass (intention-to-treat). The primary endpoint was weight loss, expressed by percentage excess body mass index (BMI) loss. The predefined clinically relevant equivalence margin was −13% to 13%. Secondary endpoints included percentage total kilograms weight loss, obesity-related comorbidities, quality of life, morbidity, and mortality. This trial is registered with Dutch Trial Register NTR4741: https://onderzoekmetmensen.nl/nl/trial/25900.
628 patients were randomised between sleeve gastrectomy (n = 312) and Roux-en-Y gastric bypass (n = 316) (mean age 43 [standard deviation (SD), 11] years; mean BMI 43.5 [SD, 4.7]; 81.8% women). Excess BMI loss at 5 years was 58.8% [95% CI, 55%–63%] after sleeve gastrectomy and 67.1% [95% CI, 63%–71%] after Roux-en-Y gastric bypass (difference 8.3% [95% CI, −12.5% to −4.0%]). This was within the predefined margin (P < 0.001). Total weight loss at 5 years was 22.5% [95% CI, 20.7%–24.3%] after sleeve gastrectomy and 26.0% [95% CI, 24.3%–27.8%] after Roux-en-Y gastric bypass (difference 3.5% [95% CI, −5.2% to −1.7%]). In both groups, obesity-related comorbidities significantly improved after 5 years. Dyslipidaemia improved more frequently after Roux-en-Y gastric bypass (83%, 54/65) compared to sleeve gastrectomy (62%, 44/71) (P = 0.006). De novo gastro-oesophageal reflux disease occurred more frequently after sleeve gastrectomy (16%, 46/288) vs Roux-en-Y gastric bypass (4%, 10/280) (P < 0.001). Minor complications were more frequent after Roux-en-Y gastric bypass (5%, 15/316) compared to sleeve gastrectomy (2%, 5/312). No statistically significant differences in major complications and health-related quality of life were encountered.
In people living with obesity grades 2 and 3, sleeve gastrectomy and Roux-en-Y gastric bypass had clinically comparable excess BMI loss according to the predefined definition for equivalence. However, Roux-en-Y gastric bypass showed significantly higher total weight loss and significant advantages in secondary outcomes, including dyslipidaemia and GERD, yet at a higher rate of minor complications. Major complications, other comorbidities, and overall HRQoL did not significantly differ between the groups.
Not applicable.</description><subject>Complications</subject><subject>GERD</subject><subject>Long-term follow-up</subject><subject>Roux-en-Y gastric bypass</subject><subject>Sleeve gastrectomy</subject><subject>Weight loss</subject><issn>2666-7762</issn><issn>2666-7762</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp9UU1v1DAQtRCIVqX_AKE5lkMW20mcDQckqCistBISHwdOlmOPt145cbCThf1N_ZN4m4I4IR88en7z3ngeIc8ZXTHKxKv9yqsBR1xxyqsM0XUpHpFzLoQomkbwx__UZ-QypT2llNes5Kx6Ss7Kdcnyac_J3TYMu2LC2ANai3qCYCF5xAPCTqUpZij0Rzgk-BzmXwUOxfflwWnojqNKCdwAI4bRI3h3cMMOfrrpFlKWiAihw-Sm42tQMN6qhLDZbKCf_eQ0DlkeohpM6F1CAzpkJHify6yvPFx9uZ_k3b3Py2fkiVU-4eXDfUG-3bz_ev2x2H76sLl-uy10RddT0ejSNq1glivFWCu6rkVb16o12jQ1rbQtWW2aytJSaCbWrULaVtowTlWDeUcX5GrRHWP4MWOaZB5Poz-tPMxJ8pbzqmZNSTO1Wqg6hpQiWjlG16t4lIzKU1JyL5ek5CkpuSSV2148OMxdj-Zv059cMuHNQsD8z4PDKJN2OGg07pSINMH93-E3M8epDg</recordid><startdate>202403</startdate><enddate>202403</enddate><creator>Biter, L Ulas</creator><creator>‘t Hart, Judith WH</creator><creator>Noordman, Bo J.</creator><creator>Smulders, J Frans</creator><creator>Nienhuijs, Simon</creator><creator>Dunkelgrün, Martin</creator><creator>Zengerink, Johannes F.</creator><creator>Birnie, Erwin</creator><creator>Friskes, Irene AM</creator><creator>Mannaerts, Guido HH</creator><creator>Apers, Jan A.</creator><general>Elsevier Ltd</general><scope>6I.</scope><scope>AAFTH</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-2239-8449</orcidid></search><sort><creationdate>202403</creationdate><title>Long-term effect of sleeve gastrectomy vs Roux-en-Y gastric bypass in people living with severe obesity: a phase III multicentre randomised controlled trial (SleeveBypass)</title><author>Biter, L Ulas ; ‘t Hart, Judith WH ; Noordman, Bo J. ; Smulders, J Frans ; Nienhuijs, Simon ; Dunkelgrün, Martin ; Zengerink, Johannes F. ; Birnie, Erwin ; Friskes, Irene AM ; Mannaerts, Guido HH ; Apers, Jan A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c408t-7c3f7961f2aa1196bb9ef55a9dcd7504cf315d74f036c1689ae094cd120a7e513</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Complications</topic><topic>GERD</topic><topic>Long-term follow-up</topic><topic>Roux-en-Y gastric bypass</topic><topic>Sleeve gastrectomy</topic><topic>Weight loss</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Biter, L Ulas</creatorcontrib><creatorcontrib>‘t Hart, Judith WH</creatorcontrib><creatorcontrib>Noordman, Bo J.</creatorcontrib><creatorcontrib>Smulders, J Frans</creatorcontrib><creatorcontrib>Nienhuijs, Simon</creatorcontrib><creatorcontrib>Dunkelgrün, Martin</creatorcontrib><creatorcontrib>Zengerink, Johannes F.</creatorcontrib><creatorcontrib>Birnie, Erwin</creatorcontrib><creatorcontrib>Friskes, Irene AM</creatorcontrib><creatorcontrib>Mannaerts, Guido HH</creatorcontrib><creatorcontrib>Apers, Jan A.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>The Lancet regional health. Europe</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Biter, L Ulas</au><au>‘t Hart, Judith WH</au><au>Noordman, Bo J.</au><au>Smulders, J Frans</au><au>Nienhuijs, Simon</au><au>Dunkelgrün, Martin</au><au>Zengerink, Johannes F.</au><au>Birnie, Erwin</au><au>Friskes, Irene AM</au><au>Mannaerts, Guido HH</au><au>Apers, Jan A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term effect of sleeve gastrectomy vs Roux-en-Y gastric bypass in people living with severe obesity: a phase III multicentre randomised controlled trial (SleeveBypass)</atitle><jtitle>The Lancet regional health. Europe</jtitle><addtitle>Lancet Reg Health Eur</addtitle><date>2024-03</date><risdate>2024</risdate><volume>38</volume><spage>100836</spage><epage>100836</epage><pages>100836-100836</pages><artnum>100836</artnum><issn>2666-7762</issn><eissn>2666-7762</eissn><abstract>Sleeve gastrectomy is the most performed metabolic surgical procedure worldwide. However, conflicting results offer no clear evidence about its long-term clinical comparability to Roux-en-Y gastric bypass. This study aims to determine their equivalent long-term weight loss effects.
This randomised open-label controlled trial was conducted from 2012 until 2017 in two Dutch bariatric hospitals with a 5-year follow-up (last follow-up July 29th, 2022). Out of 4045 patients, 628 were eligible for metabolic surgery and were randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass (intention-to-treat). The primary endpoint was weight loss, expressed by percentage excess body mass index (BMI) loss. The predefined clinically relevant equivalence margin was −13% to 13%. Secondary endpoints included percentage total kilograms weight loss, obesity-related comorbidities, quality of life, morbidity, and mortality. This trial is registered with Dutch Trial Register NTR4741: https://onderzoekmetmensen.nl/nl/trial/25900.
628 patients were randomised between sleeve gastrectomy (n = 312) and Roux-en-Y gastric bypass (n = 316) (mean age 43 [standard deviation (SD), 11] years; mean BMI 43.5 [SD, 4.7]; 81.8% women). Excess BMI loss at 5 years was 58.8% [95% CI, 55%–63%] after sleeve gastrectomy and 67.1% [95% CI, 63%–71%] after Roux-en-Y gastric bypass (difference 8.3% [95% CI, −12.5% to −4.0%]). This was within the predefined margin (P < 0.001). Total weight loss at 5 years was 22.5% [95% CI, 20.7%–24.3%] after sleeve gastrectomy and 26.0% [95% CI, 24.3%–27.8%] after Roux-en-Y gastric bypass (difference 3.5% [95% CI, −5.2% to −1.7%]). In both groups, obesity-related comorbidities significantly improved after 5 years. Dyslipidaemia improved more frequently after Roux-en-Y gastric bypass (83%, 54/65) compared to sleeve gastrectomy (62%, 44/71) (P = 0.006). De novo gastro-oesophageal reflux disease occurred more frequently after sleeve gastrectomy (16%, 46/288) vs Roux-en-Y gastric bypass (4%, 10/280) (P < 0.001). Minor complications were more frequent after Roux-en-Y gastric bypass (5%, 15/316) compared to sleeve gastrectomy (2%, 5/312). No statistically significant differences in major complications and health-related quality of life were encountered.
In people living with obesity grades 2 and 3, sleeve gastrectomy and Roux-en-Y gastric bypass had clinically comparable excess BMI loss according to the predefined definition for equivalence. However, Roux-en-Y gastric bypass showed significantly higher total weight loss and significant advantages in secondary outcomes, including dyslipidaemia and GERD, yet at a higher rate of minor complications. Major complications, other comorbidities, and overall HRQoL did not significantly differ between the groups.
Not applicable.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>38313139</pmid><doi>10.1016/j.lanepe.2024.100836</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0002-2239-8449</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | The Lancet regional health. Europe, 2024-03, Vol.38, p.100836-100836, Article 100836 |
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| source | DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Alma/SFX Local Collection |
| subjects | Complications GERD Long-term follow-up Roux-en-Y gastric bypass Sleeve gastrectomy Weight loss |
| title | Long-term effect of sleeve gastrectomy vs Roux-en-Y gastric bypass in people living with severe obesity: a phase III multicentre randomised controlled trial (SleeveBypass) |
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