腹腔镜 Nissen 360°与前 90°部分胃底折叠术的两项随机对照试验的长期随访结果。

Long-term follow-up of two randomized trials comparing laparoscopic Nissen 360° with anterior 90° partial fundoplication.

机构信息

Flinders University Department of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.

University of Adelaide Discipline of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.

出版信息

Br J Surg. 2020 Jan;107(1):56-63. doi: 10.1002/bjs.11327. Epub 2019 Sep 10.

DOI:10.1002/bjs.11327

PMID:31502659

Abstract

BACKGROUND

The side-effects of Nissen fundoplication have led to modifications, including partial fundoplications such as an anterior 90° wrap. Five-year follow-up of two randomized trials suggested fewer side-effects following anterior 90° partial fundoplication, but better reflux control after Nissen fundoplication. However, longer-term outcomes have not been reported. This study combined data from previous trials to determine 10-year outcomes.

METHODS

From 1999 to 2003, 191 patients were enrolled in two randomized trials comparing anterior 90° partial versus Nissen fundoplication. Trial protocols were similar, and data were combined to determine long-term clinical outcomes. Patients completed annual questionnaires assessing dysphagia, heartburn, medications, satisfaction and other symptoms. Visual analogue scales (0-10), a composite dysphagia score (0-45) and yes/no responses were used.

RESULTS

Of the 191 patients, 152 (79·6 per cent) were available for 10-year follow-up. After anterior 90° fundoplication, patients reported less dysphagia to solids (score 2·03 versus 3·18 for the Nissen procedure; P = 0·037). Heartburn scores were lower after Nissen fundoplication (1·90 versus 2·83 for anterior 90° fundoplication; P = 0·035) and fewer patients required proton pump inhibitors (PPIs) (22 versus 39 per cent respectively; P = 0·035). Satisfaction scores were similar for both anterior 90° and Nissen groups (7·45 versus 7·36 respectively; P = 0·566), and the majority considered their original decision for surgery to be correct (86 versus 84 per cent; P = 0·818).

CONCLUSION

After 10 years, both procedures achieved similar success as measured by global satisfaction measures. Patients who had a Nissen fundoplication reported more dysphagia, whereas more heartburn and PPI consumption were reported after anterior 90° fundoplication. Registration numbers: ACTRN12607000298415 and ACTRN12607000304437 (http://www.anzctr.org.au/).

摘要

背景

尼森胃底折叠术的副作用导致了一些改良术式，其中包括部分胃底折叠术，如前 90° wrap。两项随机试验的 5 年随访结果表明，前 90°部分胃底折叠术的副作用较少，但尼森胃底折叠术的反流控制更好。然而，尚未报道更长期的结果。本研究结合了先前试验的数据，以确定 10 年的结果。

方法

1999 年至 2003 年，191 名患者参加了两项比较前 90°部分胃底折叠术与尼森胃底折叠术的随机试验。试验方案相似，并结合数据来确定长期的临床结果。患者每年完成问卷评估吞咽困难、胃灼热、药物使用、满意度和其他症状。使用视觉模拟量表（0-10）、综合吞咽困难评分（0-45）和是/否回答。

结果

在 191 名患者中，有 152 名（79.6%）患者可进行 10 年随访。在前 90°胃底折叠术后，患者固体吞咽困难评分较低（前 90°组为 2.03，尼森组为 3.18；P=0.037）。尼森胃底折叠术后胃灼热评分较低（前 90°组为 1.90，尼森组为 2.83；P=0.035），需要质子泵抑制剂（PPIs）的患者较少（分别为 22%和 39%；P=0.035）。前 90°和尼森组的满意度评分相似（分别为 7.45 和 7.36；P=0.566），大多数患者认为他们的手术决定是正确的（分别为 86%和 84%；P=0.818）。

结论

10 年后，两种手术在全球满意度测量方面都取得了相似的成功。接受尼森胃底折叠术的患者报告的吞咽困难更多，而接受前 90°胃底折叠术的患者报告的胃灼热和 PPI 使用率更高。注册号：ACTRN12607000298415 和 ACTRN12607000304437（http://www.anzctr.org.au/）。