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临床试验/NCT02618811
NCT02618811已完成不适用

Enhanced Recovery After Surgery Protocol (ERAS) in Colorectal Surgery Diminishes the Negative Impact of Sarcopenia on Short Term Outcomes

Jagiellonian University1 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
171
试验地点
1
主要终点
Complications

研究概览

简要总结

So far, the impact of sarcopenia has been analysed only in patients undergoing traditional surgical procedures (laparotomy) or those with metastatic spread. As the ERAS protocol combined with minimally invasive access decreases postoperative metabolic disorders, it seems possible that it can limit the deleterious impact of sarcopenia as well. The aim of this study was to investigate whether the use of ERAS protocol in colorectal cancer patients influences the postoperative risk due to sarcopenia.

详细描述

The prospective observation with post-hoc analysis of 171 consecutive colorectal cancer patients was performed. In all patients 16-item ERAS protocol was applied.

Contrast-enhanced CT scan was performed preoperatively. From each scan one CT image at the level of L3 vertebra was transferred in Digital Imaging and Communications in Medicine format (DICOM) and anonymised. Firstly, the threshold range between -29 and +150 Hounsfield units was set to semi-automatically outline muscle areas, - 150 to - 50 was used for visceral adipose tissue areas, and -190 to -30 was used for subcutaneous and intermuscular adipose tissue areas. Secondly, the software calculated the surface area (cm2) of each tissue. The L3 skeletal muscle area (rectus abdominis, external and internal obliques, transversus abdominis, quadratus lumborum, psoas, erector spinae) normalized for patient height was used to calculate skeletal muscle index (SMI) (cm2/m2).

According to Martin et al. sarcopenia was defined as a SMI <41 cm2/m2 in women, <43 cm2/m2 in men with a BMI <25 kg/m2, and <53 cm2/m2 in men with a BMI >25 kg/m2 (10). To assess for myosteatosis the mean radiodensity of a L3 psoas muscle was measured. The cut-off for patients with BMI <25 kg/m2 was <41 Hounsfield units and <33 Hounsfield units for patients with BMI ≥25 kg/m2.

For the purposes of further analysis the entire group of patients was divided into subgroups depending on the presence of sarcopenia or myosteatosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • confirmed adenocarcinoma of colon or rectum
  • complete preoperative radiology assessment with abdominal CT scan
  • laparoscopic resection
  • perioperative care according to ERAS principles

排除标准

  • unavailability of a preoperative abdominal CT scan (within 30 days prior surgery)
  • emergency or initially open surgery
  • patients treated with endoscopic techniques: transanal endoscopic microsurgery (TEM), transanal total mesorectal excision (TaTME)
  • concomitant inflammatory bowel diseases.

结局指标

主要结局

Complications

时间窗: up to 30 days post surgery

次要结局

  • Mobilization on the 1st postoperative day(up to discharge from hospital, an average 6 days)
  • Need for opioid analgesia postoperatively(up to discharge from hospital, an average 6 days)
  • Hospital length of stay (days)(up to discharge from hospital, an average 6 days)
  • Compliance with ERAS protocol (%)(up to discharge from hospital, an average 6 days)
  • Tolerance of oral diet on the 1st postoperative day(up to discharge from hospital, an average 6 days)
  • Time to first flatus(up to discharge from hospital, an average 6 days)
  • Readmission rate(up to 30 days post surgery)

研究者

发起方
Jagiellonian University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michał Pędziwiatr

MD PhD

Jagiellonian University

研究点 (1)

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