Division of Surgery, Department of Clinical Science, Intervention, and Technology, Karolinska Institutet, Stockholm, Sweden.
Department of Surgery, Nyköping Hospital, Nyköping, Sweden.
JAMA Surg. 2022 Jun 1;157(6):473-480. doi: 10.1001/jamasurg.2022.0805.
The efficacy of fundoplication operations in the management of gastroesophageal reflux disease (GERD) has been documented. However, few prospective, controlled series report long-term (>10 years) efficacy and postfundoplication concerns, particularly when comparing various types of fundoplication.
To compare long-term (>15 years) results regarding mechanical complications, reflux control, and quality of life between patients undergoing posterior partial fundoplication (PF) or total fundoplication (TF) (270° vs 360°) in surgical treatment for GERD.
DESIGN, SETTING, AND PARTICIPANTS: A double-blind randomized clinical trial was performed at a single center (Ersta Hospital, Stockholm, Sweden) from November 19, 2001, to January 24, 2006. A total of 456 patients were recruited and randomized. Data for this analysis were collected from August 1, 2019, to January 31, 2021.
Laparoscopic 270° posterior PF vs 360° TF.
The main outcome was dysphagia scores for solid and liquid food items after more than 15 years. Generic (36-Item Short-Form Health Survey) and disease-specific (Gastrointestinal Symptom Rating Scale) quality of life and proton pump inhibitor consumption were also assessed.
Among 407 available patients, relevant data were obtained from 310 (response rate, 76%; mean [SD] age, 66 [11.2] years; 184 [59%] men). A total of 159 were allocated to a PF and 151 to a TF. The mean (SD) follow-up time was 16 (1.3) years. At 15 years after surgery, mean (SD) dysphagia scores were low for both liquids (PF, 1.2 [0.5]; TF, 1.2 [0.5]; P = .58) and solids (PF, 1.3 [0.6]; TF, 1.3 [0.5]; P = .97), without statistically significant differences between the groups. Reflux symptoms were equally well controlled by the 2 types of fundoplications as were the improvements of quality-of-life scores.
The long-term findings of this randomized clinical trial indicate that PF and TF are equally effective for controlling GERD and quality of life in the long term. Although PF was superior in the first years after surgery in terms of less dysphagia recorded, this difference did not prevail when assessed a decade later.
ClinicalTrials.gov Identifier: NCT04182178.
已证实胃食管反流病（GERD）的胃底折叠术治疗效果。然而，很少有前瞻性、对照系列报告长期（>10 年）疗效和胃底折叠术后的问题，特别是在比较各种类型的胃底折叠术时。
比较接受后部分胃底折叠术（PF）或全胃底折叠术（TF）（270°与 360°）治疗 GERD 的患者在机械并发症、反流控制和生活质量方面的长期（>15 年）结果。
设计、地点和参与者：这是一项单中心（瑞典斯德哥尔摩 Ersta 医院）的双盲随机临床试验，于 2001 年 11 月 19 日至 2006 年 1 月 24 日进行。共招募了 456 名患者并进行了随机分组。此分析的数据于 2019 年 8 月 1 日至 2021 年 1 月 31 日收集。
腹腔镜下 270°后 PF 与 360° TF。
主要结局是 15 年以上固体和液体食物的吞咽困难评分。还评估了一般健康状况（36-项简短健康调查）和疾病特异性（胃肠道症状评分量表）以及质子泵抑制剂的使用情况。
在 407 名可获得相关数据的患者中，310 名（应答率 76%；平均[标准差]年龄 66[11.2]岁；184 名[59%]男性）提供了相关数据。159 名患者接受 PF 治疗，151 名患者接受 TF 治疗。平均（标准差）随访时间为 16（1.3）年。术后 15 年，液体吞咽困难评分均较低（PF，1.2[0.5]；TF，1.2[0.5]；P=0.58），固体吞咽困难评分也较低（PF，1.3[0.6]；TF，1.3[0.5]；P=0.97），两组间无统计学差异。两种胃底折叠术同样能有效控制反流症状和改善生活质量评分。
这项随机临床试验的长期发现表明，PF 和 TF 在长期控制 GERD 和生活质量方面同样有效。尽管 PF 在术后头几年的吞咽困难程度较轻，但在 10 年后评估时，这种差异并不明显。
ClinicalTrials.gov 标识符：NCT04182178。
