The Intermittent Pneumoperitoneum Scheme of Work Breaks in Complex Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Stress Physiology; Staff Work Load; Artificial Pneumoperitoneum; Anuria
• Interventions: Behavioral: IPP

• Registration Number: NCT01009372
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-01
• Primary Completion: 2008-02
• Study Completion: 2009-07
• Status Verified: 2009-11
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-05
• Last Update Submitted: 2009-11-05
• Study First Posted: 2009-11-06
• Last Update Posted: 2009-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
breaks during laparoscopic surgery	IPP	Intraoperative Breaks were instituted in the intervention group. The other group operated conventionally without breaks

Primary Outcome Measures

Name	Time	Method
hormonal stress response of the operating surgeon: cortisol, amylase, testosterone, dehydroepiandrosterone (DHEA)	1 day

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hannover Medical School, Pediatric Surgery; 🇩🇪 Hannover, Lower Saxony, Germany