The Intermittent Pneumoperitoneum Scheme of Work Breaks in Complex Laparoscopic Surgery (IPP)

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

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.

Study Overview

• Status: Completed
• Conditions: Anuria; Stress Physiology; Staff Work Load; Artificial Pneumoperitoneum
• Intervention / Treatment: Behavioral: IPP

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Hannover, Lower Saxony, Germany, 30625
      • Hannover Medical School, Pediatric Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: break schemes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
hormonal stress response of the operating surgeon: cortisol, amylase, testosterone, dehydroepiandrosterone (DHEA)	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: University of Zurich; Technische Universität Dresden
• Investigators: Study Director: Benno M Ure, PhD, Hannover Medical School, 30625 Hannover

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: November 5, 2009
• First Submitted That Met QC Criteria: November 5, 2009
• First Posted (Estimate): November 6, 2009

Study Record Updates

• Last Update Posted (Estimate): November 6, 2009
• Last Update Submitted That Met QC Criteria: November 5, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: stress response; surgeon's physiology; break scheme
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: IPP 67; 4165; 3-2-2006 (Other Identifier: Ethical Commission Hannover Medical School, 30625 Hannover)