The Intermittent Pneumoperitoneum Scheme of Work Breaks in Complex Laparoscopic Surgery

NCT ID: NCT01009372

Last Updated: 2009-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-07-31

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.

Conditions

Stress Physiology; Staff Work Load; Artificial Pneumoperitoneum; Anuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

breaks during laparoscopic surgery

Intraoperative Breaks were instituted in the intervention group. The other group operated conventionally without breaks

Group Type: EXPERIMENTAL

IPP

Intervention Type: BEHAVIORAL

Institution of intraoperative breaks for the surgeon with release of pneumoperitoneum for patient

Interventions

IPP

Institution of intraoperative breaks for the surgeon with release of pneumoperitoneum for patient

Intervention Type: BEHAVIORAL

Other Intervention Names

break schemes

Eligibility 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

• Minimum Eligible Age: 4 Weeks
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Hannover Medical School

Principal Investigators

Benno M Ure, PhD

Role: STUDY_DIRECTOR

Hannover Medical School, 30625 Hannover

Locations

Hannover Medical School, Pediatric Surgery

Hanover, Lower Saxony, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 19497676 (View on PubMed)

Other Identifiers

4165; 3-2-2006

Identifier Type: OTHER

Identifier Source: secondary_id

IPP 67

Identifier Type: -

Identifier Source: org_study_id