Magnus Sundbom, Eladio Cabrera, Rickard Nyman, Charlotte Ebeling Barbier, Ulf Johnson, Mikael Ljungdahl
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The validated European Quality of life 5 Dimensions 3 level version (EQ-5D) questionnaire was used for health status measurements.</p><p><strong>Results: </strong>The procedures were successfully completed in all patients. The median operative time was 10 min for PEG and 20 min for RIG (p < 0.001). The overall rate of adverse events was lower for PEG (22%) than for RIG (51%, p = 0.002), mostly due to less local self-limiting stoma reactions and tube problems. The 30-day mortality was lower after PEG (2% versus 14%, p = 0.020). Patient-scored health status remained low for the entire cohort, with an EQ-5D utility index of 0.164. Self-rated health was low but improved in the RIG group (52.5 from 41.1, out of 100).</p><p><strong>Conclusion: </strong>PEG can be recommended as the primary procedure in patients in need of a feeding gastrostomy, mainly due to a lower frequency of tube complications. 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引用次数: 2
摘要
背景与目的:目前,经皮内镜胃造口术(PEG)是慢性严重吞咽困难患者建立永久性食管的首选方法。这是第一个在成人中比较PEG和放射插入式胃造口术(RIG)的前瞻性随机研究。方法:将106例符合两种技术条件的患者随机分为PEG(拉法)或RIG。两组在年龄、体重指数和潜在疾病方面具有可比性。术后10天和30天报告了不良事件,死亡率一直持续到6个月。采用经验证的欧洲生活质量5维度3水平版本(EQ-5D)问卷进行健康状况测量。结果:所有患者均顺利完成手术。PEG和RIG的中位手术时间分别为10 min和20 min (p < 0.001)。PEG的总体不良事件发生率(22%)低于RIG (51%, p = 0.002),主要是由于较少的局部自限性造口反应和管问题。PEG后30天死亡率较低(2%对14%,p = 0.020)。整个队列的患者健康状况评分仍然很低,EQ-5D效用指数为0.164。RIG组的自评健康水平较低,但有所改善(满分100分,41.1分,52.5分)。结论:PEG可作为饲用胃造口术患者的首选手术,主要原因是导管并发症发生率较低。然而,由于这两种技术相互补充,RIG也是一种有效的替代方法。临床试验注册:国际标准随机对照试验号ISRCTN17642761。https://doi.org/10.1186/ISRCTN17642761。
A randomized trial comparing percutaneous endoscopic gastrostomy (PEG) and radiologically inserted percutaneous gastrostomy (RIG).
Background and objective: At present, percutaneous endoscopic gastrostomy (PEG) is the procedure of choice in establishing a permanent feeding tube in patients with chronic severe dysphagia. This is the first prospective randomized study in adults comparing PEG with radiologically inserted gastrostomy (RIG).
Methods: Randomization of 106 patients, eligible for both techniques, to PEG (pull method) or RIG. The groups were comparable in terms of age, body mass index, and underlying diseases. Adverse events were reported 10 and 30 days after the operative procedure, and mortality was up until 6 months. The validated European Quality of life 5 Dimensions 3 level version (EQ-5D) questionnaire was used for health status measurements.
Results: The procedures were successfully completed in all patients. The median operative time was 10 min for PEG and 20 min for RIG (p < 0.001). The overall rate of adverse events was lower for PEG (22%) than for RIG (51%, p = 0.002), mostly due to less local self-limiting stoma reactions and tube problems. The 30-day mortality was lower after PEG (2% versus 14%, p = 0.020). Patient-scored health status remained low for the entire cohort, with an EQ-5D utility index of 0.164. Self-rated health was low but improved in the RIG group (52.5 from 41.1, out of 100).
Conclusion: PEG can be recommended as the primary procedure in patients in need of a feeding gastrostomy, mainly due to a lower frequency of tube complications. However, as the two techniques complement each other, RIG is also a valid alternative method.
Clinical trial registration: International Standard Randomized Controlled Trial Number ISRCTN17642761. https://doi.org/10.1186/ISRCTN17642761.
期刊介绍:
The Scandinavian Journal of Surgery (SJS) is the official peer reviewed journal of the Finnish Surgical Society and the Scandinavian Surgical Society. It publishes original and review articles from all surgical fields and specialties to reflect the interests of our diverse and international readership that consists of surgeons from all specialties and continents.