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临床试验/NCT01009372
NCT01009372已完成不适用

Prospective Study on the Effects of the Intermittent Pneumoperitoneum (IPP) Work Break Scheme on Surgeons and Patients.

Hannover Medical School1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2007年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
hormonal stress response of the operating surgeon: cortisol, amylase, testosterone, dehydroepiandrosterone (DHEA)

研究概览

简要总结

Many people spanning from air traffic controllers to simple production line workers share regular compulsive breaks to revert fatigue whilst they work. This is uncommon for medical operators - a macho image is still as prevalent in real life as it is in countless TV series.

We report on the first clinical trial on regular intraoperative breaks. For one time we turned our scientific curiosity to ourselves. This included the intraoperative collection of body fluids and required transparency which was not easy to obtain. It was rewarded with striking results: Regular intraoperative breaks lowered significantly the operators stress hormone levels, improved error-performance testing results and musculoskeletal fatigue scores. Subjectively the breaks enhanced the practitioners satisfaction.

Surprisingly the operator's breaks were not at the cost of the patient: because the did not prolong the overall operation time at all and - in our setting- they significantly increased of cardiac output and urine production.

详细描述

Abstract

Background: Work breaks at close intervals are common in fields with high workload but not yet for medical operators. We evaluated the effects of intraoperative breaks (five minutes every half hour) on the surgeon and on the patient.

Methods: Operations were randomized to either a scheme with intraoperative breaks and release of the pneumoperitoneum (intermittent pneumoperitoneum = IPP) or a conventional conduct (CPP). Stress hormones and α-amylase were determined in the surgeon's saliva pre-, intra- and postoperatively. Mental performance and error scores, musculoskeletal strain and continuous ECG were secondary endpoints. The children's physiology was monitored.

Findings:

Regular intraoperative breaks did not prolong the operation. The surgeon's cortisol levels during the operation were reduced. There were fewer intraoperative events in the IPP vs. the CPP group. The pre- to postoperative increase in the error rates of the bp-concentration test was reduced in the IPP group. The relevant locomotive strain-scores were reduced by IPP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
4 Weeks 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •complex laparoscopic operations in children (duration > 100 minutes)

排除标准

  • •age under 4 weeks
  • •operations which had to be performed in an open surgery mode

研究组 & 干预措施

breaks during laparoscopic surgery

Experimental

Intraoperative Breaks were instituted in the intervention group. The other group operated conventionally without breaks

干预措施: IPP (Behavioral)

结局指标

主要结局

hormonal stress response of the operating surgeon: cortisol, amylase, testosterone, dehydroepiandrosterone (DHEA)

时间窗: 1 day

次要结局

  • continuous ECG, concentration and performance (bp-test ), Self ratings of own satisfaction, performance, musculoskeletal system (MSS) and ophthalmologic strain(1 day)

研究者

申办方类型
Other

研究点 (1)

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