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袖状胃切除术中术中注射肉毒杆菌毒素:一项初步随机对照试验

Intraoperative botulinum toxin injection in sleeve gastrectomy, a pilot randomized controlled trial.

作者信息

Pradhan Grishma, Robinson Tyler D, Northrup Casey, Ata Ashar, Singh Tejinder P, Zaman Jessica A

机构信息

Department of General Surgery, Albany Medical Center, Sixth Floor, 50 New Scotland Avenue, Albany, NY, 12208, USA.

出版信息

Surg Endosc. 2025 Aug 29. doi: 10.1007/s00464-025-12066-9.

DOI:10.1007/s00464-025-12066-9
PMID:40879776
Abstract

BACKGROUND

Botulinum toxin injection of the pylorus (BP) improves gastric transit after esophagectomy (Saeed et al. in Surg Endosc 38(10):6046-52, 2024). At our institution, BP has been used as an adjunct to sleeve gastrectomy (SG) to reduce post-operative nausea and vomiting (PONV). We studied the safety and efficacy of this practice.

METHODS

A prospective, double-blinded randomized controlled trial of SG was performed with and without intraoperative BP at a large tertiary care medical center over a 3-year period was done. The primary outcome measured was safety of intraoperative BP during SG and followed by efficacy in treating PONV.

RESULTS

We performed a prospective RCT on 57 SGs performed from 2019 to 2022. There were no differences in operative time (106.8 min BP vs. 106.4 min placebo, p = 0.94) and length of stay (1.68 days BP vs. 1.48 days placebo, p = 0.40). There were no intraoperative complications and one 30-day readmission for chest pain and dehydration in the placebo group. Utilization of outpatient hydration was equivalent (7.14% BP vs 6.90% placebo, p > 0.99). Anti-emetic usage (53.57% BP and 58.62% placebo, p = 0.70) and self-reported nausea (46.43% BP and 51.72% cohort, p = 0.79) were comparable.

CONCLUSION

Intraoperative BP during SG is safe but does not improve peri-operative outcomes or patient-reported PONV when compared to standard ERAS measures. We were limited by reduction in elective bariatric case volume during the pandemic. Future study administering botulinum toxin preoperatively during endoscopy may be more successful.

摘要

背景

幽门注射肉毒杆菌毒素(BP)可改善食管切除术后的胃排空(Saeed等人,《外科内镜杂志》38(10):6046 - 52, 2024)。在我们机构,BP已被用作袖状胃切除术(SG)的辅助手段,以减少术后恶心和呕吐(PONV)。我们研究了这种做法的安全性和有效性。

方法

在一家大型三级医疗中心进行了一项为期3年的前瞻性、双盲随机对照试验,比较了SG术中使用和不使用BP的情况。主要测量结果是SG术中BP的安全性,其次是治疗PONV的有效性。

结果

我们对2019年至2022年进行的57例SG进行了前瞻性随机对照试验。手术时间(BP组106.8分钟 vs. 安慰剂组106.4分钟,p = 0.94)和住院时间(BP组1.68天 vs. 安慰剂组1.48天,p = 0.40)没有差异。术中无并发症,安慰剂组有1例因胸痛和脱水在30天内再次入院。门诊补液的使用率相当(BP组7.14% vs. 安慰剂组6.90%,p > 0.99)。止吐药的使用情况(BP组53.57%和安慰剂组58.62%,p = 0.70)和自我报告的恶心情况(BP组46.43%和队列组51.72%,p = 0.79)相当。

结论

与标准的加速康复外科措施相比,SG术中使用BP是安全的,但并不能改善围手术期结局或患者报告的PONV。我们受到疫情期间择期减肥手术病例数量减少的限制。未来在内镜检查期间术前给予肉毒杆菌毒素的研究可能会更成功。

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本文引用的文献

1
Intra-operative pyloric BOTOX injection versus pyloric surgery for prevention of delayed gastric emptying after esophagectomy.术中幽门 BOTOX 注射与幽门手术预防食管切除术后胃排空延迟。
Surg Endosc. 2024 Oct;38(10):6046-6052. doi: 10.1007/s00464-024-11151-9. Epub 2024 Aug 12.
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Significant and distinct impacts of sleeve gastrectomy and Roux-en-Y gastric bypass on esophageal acid exposure, esophageal motility, and endoscopic findings: a systematic review and meta-analysis.袖状胃切除术和 Roux-en-Y 胃旁路术对食管酸暴露、食管动力和内镜检查结果的显著而不同的影响:系统评价和荟萃分析。
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Bariatric Metabolic Surgery vs Glucagon-Like Peptide-1 Receptor Agonists and Mortality.
减重代谢手术与胰高血糖素样肽-1 受体激动剂和死亡率。
JAMA Netw Open. 2024 Jun 3;7(6):e2415392. doi: 10.1001/jamanetworkopen.2024.15392.
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The Effect of Depth of Anesthesia on Postoperative Pain in Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Trial.麻醉深度对腹腔镜袖状胃切除术术后疼痛的影响:一项随机对照试验。
Obes Surg. 2024 May;34(5):1793-1800. doi: 10.1007/s11695-024-07207-3. Epub 2024 Apr 8.
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Gut motility and hormone changes after bariatric procedures.减重手术后的肠道动力和激素变化。
Curr Opin Endocrinol Diabetes Obes. 2024 Jun 1;31(3):131-137. doi: 10.1097/MED.0000000000000860. Epub 2024 Mar 27.
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Incidence of Post-operative Gastro-esophageal Reflux Disorder in Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Systematic Review and Meta-analysis.腹腔镜袖状胃切除术患者术后胃食管反流病的发生率:一项系统评价和荟萃分析。
Obes Surg. 2024 May;34(5):1874-1884. doi: 10.1007/s11695-024-07163-y. Epub 2024 Mar 14.
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Management of postoperative nausea and vomiting in adults: current controversies.成人术后恶心呕吐的管理:当前的争议。
Curr Opin Anaesthesiol. 2021 Dec 1;34(6):695-702. doi: 10.1097/ACO.0000000000001063.
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Life Expectancy after Bariatric Surgery in the Swedish Obese Subjects Study.瑞典肥胖受试者研究中减肥手术后的预期寿命。
N Engl J Med. 2020 Oct 15;383(16):1535-1543. doi: 10.1056/NEJMoa2002449.
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Assessment of postoperative nausea and vomiting after bariatric surgery using a validated questionnaire.使用经过验证的问卷评估减重手术后的恶心和呕吐。
Surg Obes Relat Dis. 2020 Oct;16(10):1505-1513. doi: 10.1016/j.soard.2020.05.017. Epub 2020 May 28.
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Antiemetic Prophylaxis and Anesthetic Approaches to Reduce Postoperative Nausea and Vomiting in Bariatric Surgery Patients: a Systematic Review.肥胖症患者术后恶心呕吐的止吐预防和麻醉方法:系统评价。
Obes Surg. 2020 Aug;30(8):3188-3200. doi: 10.1007/s11695-020-04683-1.