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腹腔镜迷走神经阻断装置取出术:病例系列及手术技术报告。

Laparoscopic vagal nerve blocking device explantation: case series and report of operative technique.

机构信息

Department of Surgery, Oregon Health and Science University, 3181 SW Sam Jackson Park Rd, Mail Code L223A, Portland, OR, 97239, USA.

Swedish Medical Center Bariatric, Metabolic, and Endocrine Center, 1124 Columbia Street Suite 400, Seattle, WA, 98104, USA.

出版信息

Surg Endosc. 2019 Nov;33(11):3600-3604. doi: 10.1007/s00464-018-06643-4. Epub 2019 Jan 10.

DOI:10.1007/s00464-018-06643-4
PMID:30631933
Abstract

BACKGROUND

Vagal nerve blockade with the vBloc device (ReShape Lifesciences, St. Paul, MN) has been shown to provide durable 2-year weight loss in patients with moderate obesity. These devices may require removal. We present a series of patients and report our technique for laparoscopic removal of this device.

METHODS

From December 2009 to December 2016, the medical records of patients who underwent laparoscopic explantation of a vagal blocking device at our institution were retrospectively reviewed. All patients initially underwent device placement as part of a multi-center, randomized, controlled trial. The device leads were removed with the application of firm traction in order to safely dissect them away from the stomach and esophagus as the body tended to form a fibrotic capsule surrounding the leads. Operative details, length of stay, 30-day post-operative complications, demographics and reasons for device removal were reported.

RESULTS

Thirty patients were identified. Median age was 54 (37-65) years. Average operative time was 227.63 (± 100.21) min. Median time from implantation to removal was 41 (11-96) months. Removal reasons included device malfunction (7 patients, 23.3%), pain at the neuroregulator site (5 patients, 16.7%), retrosternal or epigastric pain (11 patients, 36.7%), weight regain or dissatisfaction with weight loss (15 patients, 50%), and severe nausea (2 patients, 6.7%). Two patients (6.7%) had Clavien-Dindo grade II complications following explantation. Thirteen patients (43.3%) had dense adhesions noted at the time of operation. Seroma formation at the neuroregulator site was the most common complication (7 patients, 23.3%).

CONCLUSION

The vagal nerve blocking device can be safely removed laparoscopically with a low 30-day complication rate. Surgeons should be familiar with the details of the device appearance, the typical lead location, and should anticipate dense adhesions surrounding the leads. In addition, experience operating in the region of the gastroesophageal junction is imperative.

摘要

背景

迷走神经阻滞技术通过 vBloc 设备(ReShape Lifesciences,明尼苏达州圣保罗)已被证实能为中度肥胖患者提供长达 2 年的持久减重效果。这些设备可能需要移除。我们展示了一系列患者病例,并报告了我们腹腔镜下移除该设备的技术。

方法

从 2009 年 12 月至 2016 年 12 月,回顾了我院接受腹腔镜下迷走神经阻断装置取出术的患者的病历。所有患者最初都作为多中心、随机、对照试验的一部分进行了装置放置。为了安全地将其从胃和食管上分离出来,我们应用了坚固的牵引来移除装置导丝,因为身体往往会在导丝周围形成纤维囊。报告了手术细节、住院时间、30 天术后并发症、人口统计学数据以及装置移除的原因。

结果

共确定了 30 名患者。中位年龄为 54(37-65)岁。平均手术时间为 227.63(±100.21)分钟。从植入到移除的中位时间为 41(11-96)个月。移除的原因包括装置故障(7 例,23.3%)、神经调节器部位疼痛(5 例,16.7%)、胸骨后或上腹部疼痛(11 例,36.7%)、体重反弹或对减重效果不满意(15 例,50%)以及严重恶心(2 例,6.7%)。2 例(6.7%)患者在取出后出现 Clavien-Dindo Ⅱ级并发症。13 例(43.3%)患者在手术时发现有致密粘连。神经调节器部位血清肿形成是最常见的并发症(7 例,23.3%)。

结论

迷走神经阻断装置可以通过腹腔镜安全取出,30 天并发症发生率低。外科医生应熟悉装置外观、典型导丝位置的细节,并应预料到导丝周围会有致密粘连。此外,在胃食管交界处区域有手术经验是至关重要的。

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Laparoscopic vagal nerve blocking device explantation: case series and report of operative technique.腹腔镜迷走神经阻断装置取出术:病例系列及手术技术报告。
Surg Endosc. 2019 Nov;33(11):3600-3604. doi: 10.1007/s00464-018-06643-4. Epub 2019 Jan 10.
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本文引用的文献

1
Vagal Blocking for Obesity Control: a Possible Mechanism-Of-Action.迷走神经阻滞用于控制肥胖:一种可能的作用机制
Obes Surg. 2017 Jan;27(1):177-185. doi: 10.1007/s11695-016-2278-x.
2
Update on bariatric surgical procedures and an introduction to the implantable weight loss device: the Maestro Rechargeable System.减重手术进展及可植入式减肥设备介绍:Maestro可充电系统
Med Devices (Auckl). 2016 Aug 17;9:291-9. doi: 10.2147/MDER.S106223. eCollection 2016.
3
Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial.
ReCharge试验中迷走神经阻断术(vBloc)治疗肥胖症的两年结果。
Obes Surg. 2017 Jan;27(1):169-176. doi: 10.1007/s11695-016-2325-7.
4
Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study.迷走神经阻滞对伴有肥胖相关合并症的中度肥胖患者的影响:ReCharge研究
Obes Surg. 2016 May;26(5):983-9. doi: 10.1007/s11695-016-2143-y.
5
Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial.迷走神经阻滞可实现持续体重减轻,假手术则不然:ReCharge试验的18个月结果
J Obes. 2015;2015:365604. doi: 10.1155/2015/365604. Epub 2015 Jul 12.
6
Association between bariatric surgery and long-term survival.减重手术与长期生存的关系。
JAMA. 2015 Jan 6;313(1):62-70. doi: 10.1001/jama.2014.16968.
7
Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial.可逆性间断性腹腔内迷走神经阻断对病态肥胖的影响:ReCharge 随机临床试验。
JAMA. 2014 Sep 3;312(9):915-22. doi: 10.1001/jama.2014.10540.
8
Surgery for weight loss in adults.成人减肥手术。
Cochrane Database Syst Rev. 2014 Aug 8;2014(8):CD003641. doi: 10.1002/14651858.CD003641.pub4.
9
The EMPOWER study: randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity.EMPOWER 研究:随机、前瞻性、双盲、多中心试验,旨在通过迷走神经阻断诱导病态肥胖患者体重减轻。
Obes Surg. 2012 Nov;22(11):1771-82. doi: 10.1007/s11695-012-0751-8.
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Bariatric surgery versus intensive medical therapy in obese patients with diabetes.肥胖伴糖尿病患者的减肥手术与强化内科治疗的比较。
N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.