Ergonomic Benefits From Robotically Assisted Laparoscopy for Hysterectomies and Other Indications

NCT06109753 | Completed

• 1 other identifier: MT_ASENSUS SOS
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Musculoskeletal Diseases or Conditions

Keywords

Muscular and mental demand; physical discomfort; eye strain

Outcome Measures

Primary Outcomes (1)

• Muscle activity of the bilateral trapezius pars descendens muscle

  The muscle activity of the bilateral trapezius pars descendens muscle will be assessed using surface electromyography, with the root-mean-square (RMS) of electrical muscle activity recordings measured through bipolar surface electrodes. Data will be normalized to an isometric voluntary maximum electrical activation (MVE).

  during surgery

Secondary Outcomes (8)

• Muscle activity of the bilateral forearm muscles

  during surgery

• Kinematics

  during surgery

• Perceived physical discomfort

  during surgery

• Perceived mental demand

  during surgery

• Perceived mental demand - Heart rate

  during surgery

Other Outcomes (3)

• Musculoskeletal complaints

  within the last 12 months

• Duration of the surgical procedure

  105 Minutes

• Difficulty of the surgery

  5 Minutes

Study Arms (2)

Robotically Assisted Laparoscopy

Surgeons perform robot-assisted laparoscopic surgery

Procedure: Robotically Assisted Laparoscopic Surgery

Conventional Laparoscopy

Surgeons perform conventional laparoscopic surgery

Procedure: Conventional Laparoscopic Surgery

Interventions

Robotically Assisted Laparoscopic Surgery 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

Robotically Assisted Laparoscopy

Conventional Laparoscopic Surgery 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

Conventional Laparoscopy

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

4 (males and females) gynecological surgeons

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Institute of Occupational and Social Medicine and Health Services Research, Tuebingen: collaborator

Study Sites (1)

University Women's Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Musculoskeletal Diseases; Asthenopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Benjamin Steinhilber, PD Dr.

  Institute of Occupational and Social Medicine and Health Services Research

  PRINCIPAL INVESTIGATOR

• Bernhard Krämer, Prof. Dr.

  University Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 31, 2023
• Study Start: June 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

DE (1)