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随机对照试验比较腹腔镜袖状胃切除术强化康复后治疗与标准康复路径的结局。

Randomized Controlled Trial Comparing the Outcomes of Enhanced Recovery After Surgery and Standard Recovery Pathways in Laparoscopic Sleeve Gastrectomy.

机构信息

Department of Bariatric and Metabolic Surgery, GEM Hospital & Research Center, Coimbatore, Tamil Nadu, 641045, India.

出版信息

Obes Surg. 2020 Sep;30(9):3273-3279. doi: 10.1007/s11695-020-04585-2.

Abstract

PURPOSE

The enhanced recovery after surgery (ERAS) pathway is an evidence-based perioperative pathway that results in less pain, earlier recovery, and lower complication rates. Studies to prove their efficacy over standard recovery pathways in the Indian population are scarce. Our study intends to compare the outcomes of these pathways in the Indian community focusing on hospital stay, postoperative pain, and time for rescue analgesia.

MATERIALS AND METHODS

This is a single-blinded RCT involving 112 patients who underwent laparoscopic sleeve gastrectomy (LSG). The groups were divided into ERAS and standard pathway arms by closed envelope technique. The primary outcome was the length of hospital stay, while the secondary outcomes included pain score; postoperative nausea, and vomiting (PONV); time for rescue analgesia; and ambulation.

RESULTS

Of 112 patients included, 56 were allocated in the ERAS group, and the remaining 56 were included in the standard pathway group. We found no significant differences in the baseline characteristics between the two groups. Mean hospital stay was significantly lower in the ERAS group compared to the standard group (p = 0.003). In comparison to the standard group, ERAS patients were ambulated early, and the difference was highly significant (p < 0.001). Pain scores between the two groups showed a significant difference during the 4th hour and 8th hour. We also found a significant variation between the time for first rescue analgesia and the two groups (p < 0.001).

CONCLUSION

Patients who followed ERAS protocol were found to have shortened hospital stay, decreased pain, early ambulation, and reduced need for rescue analgesia.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03191318.

摘要

目的

术后加速康复(ERAS)路径是一种基于证据的围手术期路径,可减少疼痛、加快恢复速度并降低并发症发生率。在印度人群中证明其优于标准康复路径的疗效的研究很少。我们的研究旨在比较这些路径在印度人群中的结果,重点关注住院时间、术后疼痛和需要解救性镇痛的时间。

材料和方法

这是一项单盲 RCT,涉及 112 例接受腹腔镜袖状胃切除术(LSG)的患者。通过封闭信封技术将患者分为 ERAS 组和标准路径组。主要结局是住院时间,次要结局包括疼痛评分、术后恶心和呕吐(PONV)、解救性镇痛时间和活动能力。

结果

在纳入的 112 例患者中,56 例被分配到 ERAS 组,其余 56 例被纳入标准路径组。我们发现两组患者的基线特征无显著差异。与标准组相比,ERAS 组的平均住院时间明显降低(p=0.003)。与标准组相比,ERAS 组患者更早下地活动,差异具有高度显著性(p<0.001)。两组患者的疼痛评分在第 4 小时和第 8 小时有显著差异。我们还发现两组之间首次解救性镇痛的时间存在显著差异(p<0.001)。

结论

遵循 ERAS 方案的患者住院时间缩短、疼痛减轻、更早下地活动、解救性镇痛需求减少。

试验注册

ClinicalTrials.gov 标识符:NCT03191318。

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