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

This study has been completed.
Sponsor:
Collaborators:
Dresden University of Technology
University of Zurich
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01009372
First received: November 5, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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 Intervention
Stress Physiology
Staff Work Load
Artificial Pneumoperitoneum
Anuria
Behavioral: IPP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • hormonal stress response of the operating surgeon: cortisol, amylase, testosterone, dehydroepiandrosterone (DHEA) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • continuous ECG, concentration and performance (bp-test ), Self ratings of own satisfaction, performance, musculoskeletal system (MSS) and ophthalmologic strain [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: January 2007
Study Completion Date: July 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 14 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01009372

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

Publications:
Responsible Party: Carsten Engelmann, Consultant Surgeon, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01009372     History of Changes
Other Study ID Numbers: IPP 67, 4165; 3-2-2006
Study First Received: November 5, 2009
Last Updated: November 5, 2009
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Hannover Medical School:
surgeon's physiology
stress response
break scheme

Additional relevant MeSH terms:
Anuria
Pneumoperitoneum
Kidney Diseases
Urologic Diseases
Urination Disorders
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013