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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
Sponsor:
Collaborators:
Technische Universität Dresden
University of Zurich
Information provided by:
Hannover Medical School

Brief Summary:

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

Detailed Description:

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.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
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

Arm Intervention/treatment
Experimental: breaks during laparoscopic surgery
Intraoperative Breaks were instituted in the intervention group. The other group operated conventionally without breaks
Behavioral: IPP
Institution of intraoperative breaks for the surgeon with release of pneumoperitoneum for patient
Other Name: break schemes




Primary Outcome Measures :
  1. hormonal stress response of the operating surgeon: cortisol, amylase, testosterone, dehydroepiandrosterone (DHEA) [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009372


Locations
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Germany
Hannover Medical School, Pediatric Surgery
Hannover, Lower Saxony, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Technische Universität Dresden
University of Zurich
Investigators
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Study Director: Benno M Ure, PhD Hannover Medical School, 30625 Hannover

Publications:
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Responsible Party: Carsten Engelmann, Consultant Surgeon, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01009372    
Other Study ID Numbers: IPP 67
4165; 3-2-2006 ( Other Identifier: Ethical Commission Hannover Medical School, 30625 Hannover )
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: November 6, 2009
Last Verified: November 2009
Keywords provided by Hannover Medical School:
surgeon's physiology
stress response
break scheme
Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases