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临床试验/NCT02298907
NCT02298907已完成不适用

Cardiopulmonary Exercise Variables Are Associated With Postoperative Morbidity After Major Colorectal Surgery - A Validation Study

Liverpool University Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
1
主要终点
Oxygen uptake at lactate threshold

研究概览

简要总结

The present study is a retrospective analysis of prospectively collected clinical data. Anonymized data from patients collected during routine clinical care from 7 major colorectal units in the UK who perform pre-operative cardiopulmonary exercise testing will be pooled at a central location (Aintree University Hospitals, Liverpool) and used to validate the relationship between cardiopulmonary exercise testing (CPET) variables and short term post-operative outcomes after major colorectal surgery. Here the investigators will attempt to validate a study entitled "Cardiopulmonary exercise variables are associated with postoperative morbidity after major colonic surgery - a prospective blinded observational study" previously published by our team in Liverpool .

详细描述

Patients in all the centres (Aintree University Hospitals NHS Foundation Trust, University Hospital Crosshouse NHS Foundation Trust, Barts Healthcare NHS Foundation Trust, East Kent Hospitals University NHS Foundation Trust, Lancashire Teaching Hospitals NHS Foundation Trust, South Devon Healthcare NHS Foundation Trust and Maidstone and Tunbridge Wells NHS Trust) will undergo a maximal CPET prior to major colorectal surgery (defined as a procedure involving bowel resection +/- an anastomosis or stoma) according to the CPET protocol defined in Appendix 1. If the CPET deviates from this protocol, the centre would need to clear their local CPET protocol with the Principle Investigator (PI). All variables measured by CPET which will be collected are outlined in Appendix 2.

Following the CPET, patients will undergo a major colorectal surgical procedure. Following surgery only routine clinically relevant observational data will be collected. These data will relate to hospital length of stay, the level of care required following surgery, post-operative morbidity (Postoperative Morbidity Survey - POMS and Clavine Dindo Score) and the recovery process. Most of this information can be accessed from prospectively maintained enhanced recovery databases, however patient notes and electronic patient records are acceptable alternatives. Appendix 2 shows the minimum dataset that will be collected.

All data from each individual hospital will be anonymized at source and the PI will only be sent CPET variables, post-operative outcome data, and basic patient demographics (outlined in Appendix 2) which cannot be linked back to the original patient.

We aim to include all patients aged >18 years considered for major colorectal surgery (benign or malignant) and undergoing an enhanced recovery programme after surgery. Patients will be excluded if they have diagnosis of inflammatory bowel disease, patients scheduled for neoadjuvant cancer therapy, patients physically unable to perform a CPET on a cycle ergometer, patients having no surgery performed or interim emergency surgery, patients lacking complete in-hospital morbidity data. All patients received an information sheet regarding CPET and written consent for the CPET as part of their routine care was obtained at each centre.

Hypothesis

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • all patients aged >18 years considered for major colorectal surgery (benign or malignant) and undergoing an enhanced recovery programme after surgery

排除标准

  • patients scheduled for neoadjuvant cancer therapy, patients physically unable to perform a CPET on a cycle ergometer, patients having no surgery performed or interim emergency surgery, patients lacking complete in-hospital morbidity data.

结局指标

主要结局

Oxygen uptake at lactate threshold

时间窗: baseline

次要结局

  • Oxygen uptake at peak(baseline)
  • Ventilatory equivalents at lactate threshold and peak exercise(baseline)
  • Number of patients with adverse post-operative outcome measures(post-operatively)
  • Power output at lactate threshold and peak exercise(baseline)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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