The Intermittent Pneumoperitoneum Scheme of Work Breaks in Complex Laparoscopic Surgery (IPP)
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|ClinicalTrials.gov Identifier: NCT01009372|
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : November 6, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Stress Physiology Staff Work Load Artificial Pneumoperitoneum Anuria||Behavioral: IPP||Not Applicable|
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.
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.
There was no negative impact on the patient. Interpretation: Our data support the idea that work breaks during complex laparoscopic surgery can reduce psychological stress and preserve performance with at least similar patient outcome compared to the traditional work scheme.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Prospective Study on the Effects of the Intermittent Pneumoperitoneum (IPP) Work Break Scheme on Surgeons and Patients.|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||July 2009|
Experimental: breaks during laparoscopic surgery
Intraoperative Breaks were instituted in the intervention group. The other group operated conventionally without breaks
Institution of intraoperative breaks for the surgeon with release of pneumoperitoneum for patient
Other Name: break schemes
- hormonal stress response of the operating surgeon: cortisol, amylase, testosterone, dehydroepiandrosterone (DHEA) [ Time Frame: 1 day ]
- continuous ECG, concentration and performance (bp-test ), Self ratings of own satisfaction, performance, musculoskeletal system (MSS) and ophthalmologic strain [ Time Frame: 1 day ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009372
|Hannover Medical School, Pediatric Surgery|
|Hannover, Lower Saxony, Germany, 30625|
|Study Director:||Benno M Ure, PhD||Hannover Medical School, 30625 Hannover|