Michel Gagner, Lamees Almutlaq, Gismonde Gnanhoue, J N Buchwald
{"title":"用于重度肥胖成人袖状胃切除术翻修的磁性单吻合侧对侧十二指肠-回肠造口术:1 年疗效。","authors":"Michel Gagner, Lamees Almutlaq, Gismonde Gnanhoue, J N Buchwald","doi":"10.1002/wjs.12304","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Uncomplicated surgical approaches that minimize anastomotic complications while improving revisional metabolic/bariatric surgical (MBS) outcomes are needed.</p><p><strong>Methods: </strong>This prospective single-center study assessed the feasibility, safety, and efficacy of the novel linear magnetic anastomosis system (LMAS [3 cm]) in performing a side-to-side duodeno-ileostomy (MagDI) bipartition to revise clinically suboptimal primary sleeve gastrectomy (SG). Patients with severe obesity with/without type 2 diabetes (T2D) with suboptimal weight loss, regain, and/or T2D recurrence post SG underwent revisional MagDI. A distal and proximal magnet were delivered endoscopically to the ileum and duodenum and aligned via laparoscopic assistance. Gradual magnet fusion formed a DI bipartition.</p><p><strong>Primary endpoints: </strong>technical feasibility, safety (Clavien-Dindo [CD] severe adverse event classification) at 1 year. Secondary endpoints: MBS weight and T2D reduction.</p><p><strong>Results: </strong>July 29, 2022-March 28, 2023, 24 patients (95.8% female, mean age 44.9 ± 1.5 years, and body mass index [BMI] 39.4 ± 1.3 kg/m<sup>2</sup>) underwent MagDI. Feasibility was attained via correct magnet placement (mean operative time 63.5 ± 3.3 min), patent anastomoses created, and magnet passage per anus in 100.0% of patients. There were 4 CD-III mild or moderate severe AEs, 0.0% associated with the LMAS or MagDI: 0.0% anastomotic leakage, obstruction, bleeding, infection, reintervention, or death. Mean BMI reduction was 2.1 kg/m<sup>2</sup> (p < 0.05); total weight loss 5.3%, excess weight loss 16.4%; and the patient with T2D improved.</p><p><strong>Conclusion: </strong>The single-anastomosis MagDI procedure using the novel 3-cm LMAS to revise clinically suboptimal SG was technically straightforward, incurred no major complications, mitigated weight regain, and renewed clinically meaningful weight loss.</p><p><strong>Clinicaltrials: </strong></p><p><strong>Gov identifier: </strong>NCT05322122.</p>","PeriodicalId":23926,"journal":{"name":"World Journal of Surgery","volume":null,"pages":null},"PeriodicalIF":2.3000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Magnetic single-anastomosis side-to-side duodeno-ileostomy for revision of sleeve gastrectomy in adults with severe obesity: 1-year outcomes.\",\"authors\":\"Michel Gagner, Lamees Almutlaq, Gismonde Gnanhoue, J N Buchwald\",\"doi\":\"10.1002/wjs.12304\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Uncomplicated surgical approaches that minimize anastomotic complications while improving revisional metabolic/bariatric surgical (MBS) outcomes are needed.</p><p><strong>Methods: </strong>This prospective single-center study assessed the feasibility, safety, and efficacy of the novel linear magnetic anastomosis system (LMAS [3 cm]) in performing a side-to-side duodeno-ileostomy (MagDI) bipartition to revise clinically suboptimal primary sleeve gastrectomy (SG). Patients with severe obesity with/without type 2 diabetes (T2D) with suboptimal weight loss, regain, and/or T2D recurrence post SG underwent revisional MagDI. A distal and proximal magnet were delivered endoscopically to the ileum and duodenum and aligned via laparoscopic assistance. Gradual magnet fusion formed a DI bipartition.</p><p><strong>Primary endpoints: </strong>technical feasibility, safety (Clavien-Dindo [CD] severe adverse event classification) at 1 year. Secondary endpoints: MBS weight and T2D reduction.</p><p><strong>Results: </strong>July 29, 2022-March 28, 2023, 24 patients (95.8% female, mean age 44.9 ± 1.5 years, and body mass index [BMI] 39.4 ± 1.3 kg/m<sup>2</sup>) underwent MagDI. Feasibility was attained via correct magnet placement (mean operative time 63.5 ± 3.3 min), patent anastomoses created, and magnet passage per anus in 100.0% of patients. There were 4 CD-III mild or moderate severe AEs, 0.0% associated with the LMAS or MagDI: 0.0% anastomotic leakage, obstruction, bleeding, infection, reintervention, or death. Mean BMI reduction was 2.1 kg/m<sup>2</sup> (p < 0.05); total weight loss 5.3%, excess weight loss 16.4%; and the patient with T2D improved.</p><p><strong>Conclusion: </strong>The single-anastomosis MagDI procedure using the novel 3-cm LMAS to revise clinically suboptimal SG was technically straightforward, incurred no major complications, mitigated weight regain, and renewed clinically meaningful weight loss.</p><p><strong>Clinicaltrials: </strong></p><p><strong>Gov identifier: </strong>NCT05322122.</p>\",\"PeriodicalId\":23926,\"journal\":{\"name\":\"World Journal of Surgery\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"World Journal of Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/wjs.12304\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/8/1 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"World Journal of Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/wjs.12304","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/8/1 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"SURGERY","Score":null,"Total":0}
Magnetic single-anastomosis side-to-side duodeno-ileostomy for revision of sleeve gastrectomy in adults with severe obesity: 1-year outcomes.
Introduction: Uncomplicated surgical approaches that minimize anastomotic complications while improving revisional metabolic/bariatric surgical (MBS) outcomes are needed.
Methods: This prospective single-center study assessed the feasibility, safety, and efficacy of the novel linear magnetic anastomosis system (LMAS [3 cm]) in performing a side-to-side duodeno-ileostomy (MagDI) bipartition to revise clinically suboptimal primary sleeve gastrectomy (SG). Patients with severe obesity with/without type 2 diabetes (T2D) with suboptimal weight loss, regain, and/or T2D recurrence post SG underwent revisional MagDI. A distal and proximal magnet were delivered endoscopically to the ileum and duodenum and aligned via laparoscopic assistance. Gradual magnet fusion formed a DI bipartition.
Primary endpoints: technical feasibility, safety (Clavien-Dindo [CD] severe adverse event classification) at 1 year. Secondary endpoints: MBS weight and T2D reduction.
Results: July 29, 2022-March 28, 2023, 24 patients (95.8% female, mean age 44.9 ± 1.5 years, and body mass index [BMI] 39.4 ± 1.3 kg/m2) underwent MagDI. Feasibility was attained via correct magnet placement (mean operative time 63.5 ± 3.3 min), patent anastomoses created, and magnet passage per anus in 100.0% of patients. There were 4 CD-III mild or moderate severe AEs, 0.0% associated with the LMAS or MagDI: 0.0% anastomotic leakage, obstruction, bleeding, infection, reintervention, or death. Mean BMI reduction was 2.1 kg/m2 (p < 0.05); total weight loss 5.3%, excess weight loss 16.4%; and the patient with T2D improved.
Conclusion: The single-anastomosis MagDI procedure using the novel 3-cm LMAS to revise clinically suboptimal SG was technically straightforward, incurred no major complications, mitigated weight regain, and renewed clinically meaningful weight loss.
期刊介绍:
World Journal of Surgery is the official publication of the International Society of Surgery/Societe Internationale de Chirurgie (iss-sic.com). Under the editorship of Dr. Julie Ann Sosa, World Journal of Surgery provides an in-depth, international forum for the most authoritative information on major clinical problems in the fields of clinical and experimental surgery, surgical education, and socioeconomic aspects of surgical care. Contributions are reviewed and selected by a group of distinguished surgeons from across the world who make up the Editorial Board.