短期与长期鼻胃减压对食管切除术后主要并发症的影响：一项平行组随机试验。

Effect of short-term vs prolonged nasogastric decompression on major postesophagectomy complications: a parallel-group, randomized trial.

作者信息

Mistry Rajesh C, Vijayabhaskar R, Karimundackal George, Jiwnani Sabita, Pramesh C S

机构信息

Division of Thoracic Surgery, Department of Surgical Oncology, Tata Memorial Hospital, Parel, Mumbai, India.

出版信息

Arch Surg. 2012 Aug;147(8):747-51. doi: 10.1001/archsurg.2012.1008.

DOI:10.1001/archsurg.2012.1008

PMID:22911072

Abstract

HYPOTHESIS

Controversy exists over the need for prolonged nasogastric decompression after esophagectomy. We hypothesized that early removal of the nasogastric tube would not adversely affect major pulmonary complications and anastomotic leak rates.

DESIGN

Single-center, parallel-group, open-label, randomized (1:1) trial.

SETTING

A tertiary referral cancer center with high esophagectomy volume.

PATIENTS

One hundred fifty patients undergoing esophagectomy with gastric tube reconstruction.

INTERVENTIONS

Either conventional nasogastric decompression for 6 to 10 days (75 patients) or early removal (48 hours) of nasogastric tube (75 patients) with stratification for pyloric drainage and anastomotic technique.

MAIN OUTCOME MEASURES

The primary (composite) end point was the occurrence of major pulmonary complications and anastomotic leaks. Secondary end points were the need for nasogastric tube reinsertion and patient discomfort scores. Analysis was performed on an intent-to-treat basis.

RESULTS

No significant differences were seen in the occurrence of the composite primary end point of major pulmonary and anastomotic complications between the delayed (14 of 75 patients [18.7%]) and early (16 of 75 patients [21.3%]) removal groups, respectively (P = .84). Nasogastric tube reinsertion was required more often (23 of 75 patients [30.7%] vs 7 of 75 patients [9.3%]) in the early group (P = .001). Mean patient discomfort scores were significantly higher in the delayed (+1.3; 95% CI, 0.4-2.2; P = .006) than in the early removal group. Significantly more patients in the delayed removal group (26 of 75 patients [34.7%] vs 10 of 75 patients [13.3%] in the early removal group; P = .002) identified the nasogastric tube as the tube causing the most discomfort.

CONCLUSIONS

Early removal of nasogastric tubes does not increase pulmonary or anastomotic complications after esophagectomy. Patient discomfort can be significantly reduced by early removal of the nasogastric tube.

TRIAL REGISTRATION

Clinical Trials Registry of India Identifier: CTRI/2010/091/003023.

摘要

假设

食管癌切除术后是否需要长时间鼻胃减压存在争议。我们假设早期拔除鼻胃管不会对主要肺部并发症和吻合口漏发生率产生不利影响。

设计

单中心、平行组、开放标签、随机（1:1）试验。

地点

一家食管癌切除量高的三级转诊癌症中心。

患者

150例行食管癌切除并胃管重建的患者。

干预措施

要么进行6至10天的传统鼻胃减压（75例患者），要么早期（48小时）拔除鼻胃管（75例患者），并根据幽门引流和吻合技术进行分层。

主要观察指标

主要（复合）终点是主要肺部并发症和吻合口漏的发生情况。次要终点是再次插入鼻胃管的必要性和患者不适评分。分析采用意向性分析。

结果

延迟拔除组（75例患者中有14例[18.7%]）和早期拔除组（75例患者中有16例[21.3%]）主要肺部和吻合口并发症复合主要终点的发生率无显著差异（P = 0.84）。早期组需要再次插入鼻胃管的情况更常见（75例患者中有23例[30.7%]，而75例患者中有7例[9.3%]）（P = 0.001）。延迟组患者的平均不适评分（+1.3；95%CI，0.4 - 2.2；P = 0.006）显著高于早期拔除组。延迟拔除组中更多患者（75例患者中有26例[34.7%]，而早期拔除组中75例患者中有10例[13.3%]；P = 0.002）认为鼻胃管是造成最不适的管道。