Ergonomic Benefits from Robotically Assisted Laparoscopy for Hysterectomies and Other Indications

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

RECRUITING

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2026-06-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Musculoskeletal Diseases or Conditions

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Robotically Assisted Laparoscopy

Surgeons perform robot-assisted laparoscopic surgery

Robotically Assisted Laparoscopic Surgery

Intervention Type PROCEDURE

robotically assisted surgeries of about 60-minute duration with additional 30 min for preparing with the measurement equipment before surgery and 15 post evaluation of the corresponding surgery

Conventional Laparoscopy

Surgeons perform conventional laparoscopic surgery

Conventional Laparoscopic Surgery

Intervention Type PROCEDURE

conventional surgeries of about 60-minute duration with additional 30 min for preparing with the measurement equipment before surgery and 15 post evaluation of the corresponding surgery

Interventions

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Robotically Assisted Laparoscopic Surgery

robotically assisted surgeries of about 60-minute duration with additional 30 min for preparing with the measurement equipment before surgery and 15 post evaluation of the corresponding surgery

Intervention Type PROCEDURE

Conventional Laparoscopic Surgery

conventional surgeries of about 60-minute duration with additional 30 min for preparing with the measurement equipment before surgery and 15 post evaluation of the corresponding surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No