Work Breaks During Simulated Minimally Invasive Surgery

NCT ID: NCT03715816

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2020-10-14

Brief Summary

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Minimally invasive surgeons have a prevalence of work-related musculoskeletal complaints of up to 86% due to the exposure to static loading, awkward postures, work pressure, and patient's wellbeing. Researchers have developed postural interventions to counteract the prevalence of musculoskeletal complaints and disorders, such as robot-assisted surgeries, arm-support systems, and rotatable handle pieces. An alternative intervention is to implement work breaks during the surgeries, which has shown to give promising results including that surgery duration does not prolong.

The aim of the current study is to simulate 90-min laparoscopic surgery activities in the laboratory and compare two intervention situations with the control situation. The control situation is without work breaks. The two intervention situations include 2.5-min breaks provided two times, i.e. after every 30-min work period, which are passive (rest) or active (targeted mobilization exercises). The assessment is based on changes in muscular activity on the back and upper extremities, back and upper extremity postures, feelings of discomfort, and work performance.

Detailed Description

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Conditions

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Work-break Schedules

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

The study is not blinded, because the subject(s) will know which of the three experimental conditions they are exposed to (control without breaks; intervention with passive or active breaks). The same applies to the experimenter(s).

Study Groups

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No breaks

Subjects will simulate a 90-min laparoscopic activities in the laboratory.

Group Type NO_INTERVENTION

No interventions assigned to this group

Passive breaks

Subjects will simulate a 90-min laparoscopic activities in the laboratory, and after 30 and 60 min of work, they will be provided a 2.5-min break during which they can have a rest.

Group Type EXPERIMENTAL

Work break schedule

Intervention Type BEHAVIORAL

Participants will receive 2.5-min breaks during a 90-min simulated laparoscopic surgery in the laboratory. The breaks will be either passive (simple rest) or active (selected mobilization exercises).

Active breaks

Subjects will simulate a 90-min laparoscopic activities in the laboratory, and after 30 and 60 min of work, they will be provided a 2.5-min break during which they will be performing some mobilisation exercises for the back, shoulder, and neck.

Group Type EXPERIMENTAL

Work break schedule

Intervention Type BEHAVIORAL

Participants will receive 2.5-min breaks during a 90-min simulated laparoscopic surgery in the laboratory. The breaks will be either passive (simple rest) or active (selected mobilization exercises).

Interventions

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Work break schedule

Participants will receive 2.5-min breaks during a 90-min simulated laparoscopic surgery in the laboratory. The breaks will be either passive (simple rest) or active (selected mobilization exercises).

Intervention Type BEHAVIORAL

Other Intervention Names

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passive break active break

Eligibility Criteria

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Inclusion Criteria

* (Student) surgeons, who are familiar with laparoscopic procedures and / or simulated laparoscopic procedures;
* Be able to perform the Peg-Transfer task (Simulab, Seattle, WA, USA) within 3 minutes;
* The participant will give her/his voluntary informed consent after receiving oral and written information of the content and goal of the study.

Exclusion Criteria

* (Student) surgeons who are not familiar with laparoscopic procedures and / or simulated laparoscopic procedures;
* Not able to perform the Peg-Transfer task within 3 minutes;
* People under the influence of intoxicants, analgesics, or muscle relaxants;
* Alcohol abuse;
* People with cardiovascular diseases;
* People with a heart pacemaker;
* People with a disability who, due to their restriction at a workplace of this kind, will not be able to participate;
* People with Diabetes Mellitus;
* People with severe muscle contractions of the lower extremities, back or arms;
* People with acute ailments or pain, which make(s) them unable to participate;
* People who are unable to complete the examination program due to language or cognitive obstacles;
* Depending on the degree of severity, people with diseases of the veins and joints of the lower extremities, spine, muscle disorders, symptomatic neurological-psychiatric diseases, acute pain syndromes, maladies or other current diseases.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Dr. Tessy Luger

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Occupational and Social Medicine and Health Services Research, University Hospital Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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Luger T, Rieger MA, Bonsch R, Kramer B, Seibt R, Steinhilber B. Active and passive work breaks during simulated laparoscopy among laparoscopic surgeons: study protocol for a controlled, randomised cross-over laboratory trial. BMJ Open. 2020 Nov 19;10(11):e038952. doi: 10.1136/bmjopen-2020-038952.

Reference Type BACKGROUND
PMID: 33444192 (View on PubMed)

Luger T, Bonsch R, Seibt R, Kramer B, Rieger MA, Steinhilber B. Intraoperative active and passive breaks during minimally invasive surgery influence upper extremity physical strain and physical stress response-A controlled, randomized cross-over, laboratory trial. Surg Endosc. 2023 Aug;37(8):5975-5988. doi: 10.1007/s00464-023-10042-9. Epub 2023 Apr 21.

Reference Type DERIVED
PMID: 37084097 (View on PubMed)

Related Links

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http://www.premus2019.com/wp-content/uploads/2019/09/PREMUS-2019-Abstact-30.08.19.pdf

Page 285: poster presentation with preliminary results presented at the PREMUS 2019 conference in Bologna, Italy

Other Identifiers

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UKT-2018AS0-1835

Identifier Type: -

Identifier Source: org_study_id

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