The Intermittent Pneumoperitoneum Scheme of Work Breaks in Complex Laparoscopic Surgery

Stress Physiology Clinical Trial

— IPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009372
• Other study ID #: IPP 67
• Secondary ID: 4165; 3-2-2006
• Status: Completed
• Phase: N/A
• First received: November 5, 2009
• Last updated: November 5, 2009
• Start date: January 2007
• Est. completion date: July 2009

Study information

• Verified date: November 2009
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2009
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anuria
• Artificial Pneumoperitoneum
• Pneumoperitoneum
• Staff Work Load
• Stress Physiology

Intervention

Behavioral:
• IPP
Institution of intraoperative breaks for the surgeon with release of pneumoperitoneum for patient

Locations

Country	Name	City	State
Germany	Hannover Medical School, Pediatric Surgery	Hannover	Lower Saxony

Sponsors (3)

Lead Sponsor	Collaborator
Hannover Medical School	Technische Universität Dresden, University of Zurich

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Kumari M, Badrick E, Chandola T, Adam EK, Stafford M, Marmot MG, Kirschbaum C, Kivimaki M. Cortisol secretion and fatigue: associations in a community based cohort. Psychoneuroendocrinology. 2009 Nov;34(10):1476-85. doi: 10.1016/j.psyneuen.2009.05.001. Epub 2009 Jun 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hormonal stress response of the operating surgeon: cortisol, amylase, testosterone, dehydroepiandrosterone (DHEA)		1 day	No
Secondary	continuous ECG, concentration and performance (bp-test ), Self ratings of own satisfaction, performance, musculoskeletal system (MSS) and ophthalmologic strain		1 day	No