SurgOne, PC, 401 W Hampden Pl., Englewood, CO 90110, USA.
J Am Coll Surg. 2012 Dec;215(6):794-809. doi: 10.1016/j.jamcollsurg.2012.07.014. Epub 2012 Aug 29.
This study was undertaken to validate previously reported safety and symptomatic outcomes of transoral incisionless fundoplication (TIF), evaluate the relative benefit of TIF within different gastroesophageal reflux disease (GERD) subgroups, and to determine predictors of success in community settings.
Between January 2010 and February 2011, 100 consecutive patients who underwent TIF procedures at 10 centers were enrolled in this prospective, open-label, multicenter, single-arm study. Symptom improvement and objective outcomes of TIF were analyzed at 6-month follow-up.
One hundred TIF procedures were performed. No complications were reported. Median GERD symptom duration was 9 years (range 1 to 35 years) and median duration of proton pump inhibitor (PPI) use was 7 years (1 to 20 years). Maximal medical therapy resulted in incomplete symptom control for 92% of patients; GERD Health-Related Quality of Life (GERD-HRQL) total score was normalized in 73%. Median heartburn and regurgitation scores improved significantly, from 18 (range 0 to 30) and 15 (range 0 to 30) on PPIs before TIF to 3 (range 0 to 25) and 0 (range 0 to 25), respectively; p < 0.001. Median Reflux Symptom Index scores were reduced after TIF from 24 (range 14 to 41) to 7 (range 0 to 44); p < 0.001. Eighty percent of patients were completely off PPIs after TIF vs 92% of patients on PPIs before TIF. Preoperative factors associated with clinical outcomes were less severe heartburn (total GERD-HRQL ≤ 30, p = 0.02) and the presence of esophagitis (p < 0.02).
Transoral incisionless fundoplication is safe and effective in multiple community-based settings in the treatment of medically refractory GERD, as demonstrated by an absence of complications, excellent symptom relief, and complete cessation of PPIs at 6-month follow-up.
本研究旨在验证先前报道的经口无切口胃底折叠术（TIF）的安全性和症状结果，评估 TIF 在不同胃食管反流病（GERD）亚组中的相对益处，并确定社区环境中成功的预测因素。
在 2010 年 1 月至 2011 年 2 月期间，在 10 个中心进行 TIF 手术的 100 例连续患者被纳入这项前瞻性、开放标签、多中心、单臂研究。在 6 个月的随访时分析 TIF 的症状改善和客观结果。
共进行了 100 例 TIF 手术。未报告并发症。GERD 症状持续时间中位数为 9 年（范围 1 至 35 年），质子泵抑制剂（PPI）使用时间中位数为 7 年（1 至 20 年）。最大的药物治疗导致 92%的患者症状控制不完全；胃食管反流病健康相关生活质量（GERD-HRQL）总评分正常化 73%。烧心和反流评分中位数显著改善，从 TIF 前的 PPI 时的 18 （范围 0 至 30）和 15 （范围 0 至 30）分别改善至 3 （范围 0 至 25）和 0 （范围 0 至 25）；p < 0.001。TIF 后反流症状指数评分中位数从 24 （范围 14 至 41）降至 7 （范围 0 至 44）；p < 0.001。80%的患者在 TIF 后完全停用 PPI，而 TIF 前的患者为 92%。与临床结果相关的术前因素是较轻的烧心（总 GERD-HRQL ≤ 30，p = 0.02）和食管炎的存在（p < 0.02）。
经口无切口胃底折叠术在多个社区环境中治疗药物难治性 GERD 是安全有效的，在 6 个月的随访时无并发症、症状缓解极佳以及完全停止使用 PPI 得到证实。
