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

Primary Purpose

Stress Physiology, Staff Work Load, Artificial Pneumoperitoneum

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
IPP
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stress Physiology focused on measuring surgeon's physiology, stress response, break scheme

Eligibility Criteria

4 Weeks - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hannover Medical School, Pediatric Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

breaks during laparoscopic surgery

Arm Description

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

Outcomes

Primary Outcome Measures

hormonal stress response of the operating surgeon: cortisol, amylase, testosterone, dehydroepiandrosterone (DHEA)

Secondary Outcome Measures

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

Full Information

First Posted
November 5, 2009
Last Updated
November 5, 2009
Sponsor
Hannover Medical School
Collaborators
Technische Universität Dresden, University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01009372
Brief Title
The Intermittent Pneumoperitoneum Scheme of Work Breaks in Complex Laparoscopic Surgery
Acronym
IPP
Official Title
Prospective Study on the Effects of the Intermittent Pneumoperitoneum (IPP) Work Break Scheme on Surgeons and Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hannover Medical School
Collaborators
Technische Universität Dresden, University of Zurich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Physiology, Staff Work Load, Artificial Pneumoperitoneum, Anuria
Keywords
surgeon's physiology, stress response, break scheme

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
breaks during laparoscopic surgery
Arm Type
Experimental
Arm Description
Intraoperative Breaks were instituted in the intervention group. The other group operated conventionally without breaks
Intervention Type
Behavioral
Intervention Name(s)
IPP
Other Intervention Name(s)
break schemes
Intervention Description
Institution of intraoperative breaks for the surgeon with release of pneumoperitoneum for patient
Primary Outcome Measure Information:
Title
hormonal stress response of the operating surgeon: cortisol, amylase, testosterone, dehydroepiandrosterone (DHEA)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
continuous ECG, concentration and performance (bp-test ), Self ratings of own satisfaction, performance, musculoskeletal system (MSS) and ophthalmologic strain
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benno M Ure, PhD
Organizational Affiliation
Hannover Medical School, 30625 Hannover
Official's Role
Study Director
Facility Information:
Facility Name
Hannover Medical School, Pediatric Surgery
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19497676
Citation
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.
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The Intermittent Pneumoperitoneum Scheme of Work Breaks in Complex Laparoscopic Surgery

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