The Intermittent Pneumoperitoneum Scheme of Work Breaks in Complex Laparoscopic Surgery

NCT01009372 | Completed DMC

• 2 other identifiers: IPP 674165; 3-2-2006
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Physiology; Staff Work Load; Artificial Pneumoperitoneum; Anuria

Keywords

surgeon's physiology; stress response; break scheme

Outcome Measures

Primary Outcomes (1)

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

  1 day

Secondary Outcomes (1)

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

  1 day

Study Arms (1)

breaks during laparoscopic surgery

EXPERIMENTAL

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

Behavioral: IPP

Interventions

IPP BEHAVIORAL

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

Also known as: break schemes

breaks during laparoscopic surgery

Eligibility Criteria

• Age: 4 Weeks - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• complex laparoscopic operations in children (duration \> 100 minutes)

You may not qualify if:

• age under 4 weeks
• operations which had to be performed in an open surgery mode

Sponsors & Collaborators

• Hannover Medical School: lead
• Technische Universität Dresden: collaborator
• University of Zurich: collaborator

Study Sites (1)

Hannover Medical School, Pediatric Surgery

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (1)

• 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.

  PMID: 19497676 BACKGROUND

MeSH Terms

Conditions

Anuria; Fractures, Stress

Interventions

indolepropanol phosphate

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urination Disorders; Male Urogenital Diseases; Fractures, Bone; Wounds and Injuries

Study Officials

• Benno M Ure, PhD

  Hannover Medical School, 30625 Hannover

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 6, 2009
• Study Start: January 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: July 1, 2009
• Last Updated: November 6, 2009

Record last verified: 2009-11

Locations

DE (1)