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Ergonomic Benefits From Robotically Assisted Laparoscopy for Hysterectomies and Other Indications (ERCON)

U

University Hospital Tuebingen

Status

Completed

Conditions

Musculoskeletal Diseases or Conditions

Treatments

Procedure: Conventional Laparoscopic Surgery
Procedure: Robotically Assisted Laparoscopic Surgery

Study type

Observational

Funder types

Other

Identifiers

NCT06109753
MT_ASENSUS SOS

Details and patient eligibility

About

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

Full 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.

Enrollment

4 patients

Sex

All

Ages

18 to 68 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

4 participants in 2 patient groups

Robotically Assisted Laparoscopy
Description:
Surgeons perform robot-assisted laparoscopic surgery
Treatment:
Procedure: Robotically Assisted Laparoscopic Surgery
Conventional Laparoscopy
Description:
Surgeons perform conventional laparoscopic surgery
Treatment:
Procedure: Conventional Laparoscopic Surgery

Trial contacts and locations

1

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Central trial contact

Bernhard Krämer, Prof. Dr.

Data sourced from clinicaltrials.gov

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