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临床试验/NCT04343911
NCT04343911已完成不适用

Position-related Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery - a Comparative Single-center Prospective Cohort Study

Copenhagen University Hospital, Hvidovre0 个研究点目标入组 207 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
207
主要终点
position related postoperative peripheral neuropathy

研究概览

简要总结

This prospective cohort study of patients undergoing colorectal surgery positioned conventionally with shoulder braces was performed. After initial results the implementation of the Pink Pad ® took place in order to compare the two groups. This study favours Pink Pad over conventional positioning concerning postoperative neuropathy.

详细描述

Laparoscopic colorectal surgery requires perioperative positioning in the dorsal lithotomy position and intermittent Trendelenburg position, which is associated with postoperative peripheral neuropathy, which is a substantial cause of anesthesia-related claims. This study aims to primarily assess the incidence of postoperative peripheral neuropathy of patients positioned conventionally by shoulder braces and secondly to compare this group with patients positioned on the foam mattress Pink Pad ® 24-hours after surgery and secondarily at a 30-day postoperative follow-up.

This consecutive single-center prospective cohort study of 155 patients undergoing colorectal surgery was performed between November 2014 and June 2015. After initial results the implementation of the Pink Pad ® took place and a total of 52 patients were included between May 2016 and February 2017 in order to compare the two groups.

Position related postoperative peripheral neuropathy is an important complication after laparoscopic colorectal surgery. This study concludes that careful attention should be payed to positioning and favors Pink Pad ® over conventional positioning with shoulder braces.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Age >18 years
  • Elective laparoscopic colorectal surgery
  • Sufficient written and verbal Danish skills
  • Awake, responsive and oriented in the post-surgical inclusion period

排除标准

  • Pre-existing peripheral neuro- or musculopathy,
  • Conversion to open operation
  • Lack of consent were defined as exclusion criteria.

结局指标

主要结局

position related postoperative peripheral neuropathy

时间窗: 24-hours after surgery

This study's primary outcome is to evaluated the incidence of postoperative peripheral neuropathy in patients positioned conventionally compared to patients positioned on the Pink Pad foam mattress 24-hours after surgery.

次要结局

  • Position related postoperative peripheral neuropathy(30 day follow-up after surgery)

研究者

发起方
Copenhagen University Hospital, Hvidovre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Signe Amalie Wolthers Laursen

Principal Investigator and Specialist Registrar in Anesthesiology

Copenhagen University Hospital, Hvidovre

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