Ignite Creation Date:
2024-05-05 @ 10:00 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01009372
Status:
COMPLETED
Last Update Posted:
2009-11-06
First Post:
2009-11-05
Brief Title:
The Intermittent Pneumoperitoneum Scheme of Work Breaks in Complex Laparoscopic Surgery
Sponsor:
Hannover Medical School
Organization:
Hannover Medical School
Study Overview
Official Title:
Prospective Study on the Effects of the Intermittent Pneumoperitoneum IPP Work Break Scheme on Surgeons and Patients
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPP
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 operators 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
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 operators 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 surgeons saliva pre- intra- and postoperatively Mental performance and error scores musculoskeletal strain and continuous ECG were secondary endpoints The childrens physiology was monitored
Findings
Regular intraoperative breaks did not prolong the operation The surgeons 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
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 surgeons saliva pre- intra- and postoperatively Mental performance and error scores musculoskeletal strain and continuous ECG were secondary endpoints The childrens physiology was monitored
Findings
Regular intraoperative breaks did not prolong the operation The surgeons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4165 3-2-2006 | OTHER | Ethical Commission Hannover Medical School 30625 Hannover | None |