Clinical trial NCT06109753: Ergonomic Benefits from Robotically Assisted Laparoscopy for Hysterectomies and Other Indications
Official title: Ergonomic Benefits from Robotically Assisted Laparoscopy for Hysterectomies and Other Selected Indications in Comparison to Conventional Laparoscopy - an Explorative Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Musculoskeletal Diseases or Conditions
Keywords: Muscular and mental demand
physical discomfort
eye strain
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Institute of Occupational and Social Medicine and Health Services Research, Tuebingen
First posted: 2023-10-31
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 4 (males and females) gynecological surgeons

Brief summary: This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen.

Detailed description: Monocentric trial to evaluate differences in musculoskeletal and cognitive demands of robot-assisted laparoscopic surgery (RALS) vs. conventional laparoscopic surgery (CLS). Demographic and personal data are collected and pseudonymized. During surgery surface electromyography (EMG), electrocardiography (ECG), motion tracking data are collected and the surgery is documented by photos (1 photo/per second). Additionally, perceived physical discomfort (frequency and intensity) and mental load will be assessed within certain time intervals and at the very end of the surgery. The surgeon will not be disturbed in his actions and movement by the measurement equipment or applied procedures. Previous studies with similar designs can be seen as references in this context (549/2012BO1, 409/2013BO1, 262/2018BO1). After completing the surgery, the surgeon will rate difficulty of the surgery, work precision, eye strain and ergonomics during the surgery. Routine interventions like hysterectomies and other selected indications will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 68 years
* surgeons that are able to work in full shift
* trained surgeons in RALS and CLS
* written informed consent

Exclusion Criteria:

* persons influenced by analgesics or muscle relaxants
* persons not able to perform their common work for any reason
* persons with acute diseases
* muscle injury

Primary outcomes:
measure: Muscle activity of the bilateral trapezius pars descendens muscle
timeFrame: during surgery
Secondary outcomes:
measure: Muscle activity of the bilateral forearm muscles
timeFrame: during surgery
measure: Kinematics
timeFrame: during surgery
measure: Perceived physical discomfort
timeFrame: during surgery
measure: Perceived mental demand
timeFrame: during surgery
measure: Perceived mental demand - Heart rate
timeFrame: during surgery
measure: Perceived mental demand - Heart rate variability
timeFrame: during surgery
measure: Work precision
timeFrame: during surgery
measure: Eye strain
timeFrame: during surgery
Other outcomes:
measure: Musculoskeletal complaints
timeFrame: within the last 12 months
measure: Duration of the surgical procedure
timeFrame: 105 Minutes
measure: Difficulty of the surgery
timeFrame: 5 Minutes
Locations:
city: Tübingen
country: Germany
facility: University Women's Hospital
state: Baden-Württemberg
Study officials:
affiliation: Institute of Occupational and Social Medicine and Health Services Research
name: Benjamin Steinhilber, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Women's Hospital
name: Bernhard Krämer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: