School of Medicine, Vita-Salute San Raffaele University, Milan, Italy.
Division of Gastroenterology and Gastrointestinal Endoscopy, San Raffaele Scientific Institute, Milan, Italy.
Endoscopy. 2020 Jun;52(6):469-473. doi: 10.1055/a-1124-3187. Epub 2020 Mar 18.
Transoral incisionless fundoplication (TIF) with the Medigus ultrasonic surgical endostapler (MUSE) is a new intervention for the treatment of the gastroesophageal reflux disease (GERD). The aim of this study was to assess the 12-month clinical, functional, and endoscopic effects of TIF by MUSE.
Patients undergoing MUSE completed the GERD-Health Related Quality of Life (GERD-HRQL) and Reflux Symptom Index (RSI) questionnaires, and underwent endoscopy, esophageal 24-hour pH-impedance recording, and high resolution manometry (HRM) before the TIF procedure and 12 months later, or after 6 months for HRM.
Among the 37 patients treated, esophageal intubation was not possible in one and esophageal perforation occurred in another. Clinical and endoscopic follow-up at 12 months was completed in 20 patients, with significant improvements in GERD-HRQL, RSI, heartburn, regurgitation scores, and proton pump inhibitor (PPI) consumption observed. One patient required surgery for persisting symptoms. Functional follow-up was possible in 13 patients and showed no significant improvements in the analyzed parameters.
TIF with MUSE significantly improved symptoms at 1-year follow-up, allowing the consumption of PPIs to be stopped or halved in 90 % of patients.
经口无切口胃底折叠术（TIF）联合 Medigus 超声外科吻合器（MUSE）是一种治疗胃食管反流病（GERD）的新方法。本研究旨在评估 MUSE 行 TIF 术 12 个月的临床、功能和内镜疗效。
接受 MUSE 治疗的患者在 TIF 术前及术后 12 个月（或 HRM 术后 6 个月）完成 GERD 健康相关生活质量（GERD-HRQL）和反流症状指数（RSI）问卷、内镜检查、食管 24 小时 pH-阻抗监测和高分辨率测压（HRM）。
37 例患者中，1 例因食管插管困难，另 1 例发生食管穿孔。20 例患者完成了 12 个月的临床和内镜随访，GERD-HRQL、RSI、烧心、反流评分和质子泵抑制剂（PPI）使用率均显著改善。1 例患者因持续症状而行手术治疗。13 例患者行功能随访，分析参数无显著改善。
MUSE 行 TIF 术可显著改善患者症状，90%的患者可停用或减半使用 PPI。
