Surgeon Ergonomics in Robotic-assisted Laparoscopic Vs Standard Laparoscopic Surgery

NCT04477746 | Completed

• 1 other identifier: FHMREC19052
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

Musculoskeletal injuries amongst surgeons are prevalent. This project will determine whether Robotic-assisted Laparoscopic surgery (RALS) offers superior benefits to surgeon's musculoskeletal health than standard laparoscopic surgery (LS), by identifying the comparative changes in muscle fatigue during RALS Vs LS surgical procedures, and additionally identify any cognitive effects of this. The Study if successful, could help reduce injury rates in surgeons.

Conditions

Musculoskeletal Pain; Musculoskeletal Strain; Fatigue; Muscle, Heart; Cognitive Impairment

Keywords

Robot-Assisted Laparoscopic; Standard Laparoscopic

Outcome Measures

Primary Outcomes (1)

• EMG measurements of Maximal Voluntary Contraction (MVC), frequency and amplitude of contractions across muscle fibres to establish the musculoskeletal demands (demonstrated as muscle fatigue) of RALS and LS surgery

  Over the 12 weeks of participants involvement in study

Secondary Outcomes (1)

• EEG measurements of peak alpha power, and alpha spindle duration and amplitude during the surgical procedures to determine if changes in musculoskeletal demands are associated with changes in motor control and cognitive fatigue.

  Over the 12 weeks of participants involvement in study

Study Arms (2)

Standard Laparoscopy group (LS)

7 surgeons performing surgical procedures using the standard laparoscopic approach

Robot- assisted laparoscopic group (RALS)

6 surgeons performing surgical procedures using the robot-assisted laparoscopic approach

Eligibility Criteria

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

Study Population

Surgeons: We will recruit 8 - 10 surgeons per study group (RALS and LS) from four specialties; Urology, Gynaecology, Colorectal and Hepatobiliary Surgery, with experience in RALS and LS. They will be monitored performing Four procedures that are broadly 2-hour long. They will broadly be matched for age and surgical experience, anthropometry, and sex. They will fill a questionnaire regarding working hours and experience, physical activity level, general health conditions and musculoskeletal symptoms within the last 12 months using the Standardized Nordic questionnaires for the analysis of musculoskeletal symptoms (11). We will quantify body composition using clinically validated bioelectrical impedance analysis. Patients: To complete the work, we will use the data obtained from surgeons operating on n = 40 patients in RALS and n = 40 LS groups. Patients will be matched for characteristics including sex, age, body mass index (BMI), and pre-operative risk scores.

You may qualify if:

• Healthy surgeons with experience in performing procedures using LS and/or RALS.

You may not qualify if:

• Significant co-morbidities
• Significant musculoskeletal symptoms
• Procedures that include major complications or requiring \>50% more time than the mean average

Sponsors & Collaborators

• Lancaster University: lead
• National Health Service, United Kingdom: collaborator

Study Sites (2)

East Lancashire Hospitals NHS Trust

Blackburn, Lancashire, BB2 3HH, United Kingdom

Location

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, Lancashire, PR2 9HT, United Kingdom

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Fatigue; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: November 12, 2020
• Primary Completion: October 30, 2021
• Study Completion: March 30, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

GB (2)