Versius Or Laparoscopic Colorectal Cancer and Non-cancer Operation Outcomes

Colorectal Disorders Clinical Trial

— VOLCANO  

Official title:

A Single Blinded Randomised Controlled Trial Comparing the Ergonomics of Laparoscopic and Versius Robotic Assisted Colorectal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05262296
• Other study ID #: MKUH-RD-020
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2024
• Source: Milton Keynes University Hospital NHS Foundation Trust
• Contact: Joanne Turner
• Phone: +441908995136
• Email: joanne.turner[@]mkuh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a study comparing major bowel surgery done via conventional keyhole (laparoscopic) surgery with robotic assisted keyhole surgery, using the Versius robotic system. Our main objective is to assess the physical strain of both types of surgery on the operating surgeon, but we will also collect data on the patient outcomes and teamwork. This results from this study will be used to guide the design of a larger scale trial in future.

Description:

This study has been designed to assess the ergonomics of Versius® assisted surgery in comparison with laparoscopic surgery in the management of major colorectal resection. The study will randomise 60 patients who require removal of either part or all of the colon or rectum and have been deemed suitable for a minimally invasive approach, as management of either benign or malignant colorectal pathology.

Patients will be randomised to receive either laparoscopic or Versius® robotic assisted surgery but will be informed that it will be attempted via a minimally invasive approach that could include either of these two subtypes of minimally invasive surgery. The randomisation will occur on a 2:1 basis, with 2 patients allocated to the robotic arm for every 1 patient allocated to the laparoscopic arm. Laparoscopic surgery is already a well-established technique, and therefore the study team believe more valuable data about the outcomes of robotic surgery will be obtained with this randomisation ratio given that no prior studies have been undertaken using this robotic platform.

All surgeons in the study will be required to have been involved in at least 20 cases performed using the relevant modality, whether for the robotic or laparoscopic cohorts.

Data will be collected at four key timepoints; recruitment, intraoperatively, at discharge and again at 28 days following intervention. Feasibility outcomes will include willingness to be recruited to study (acceptability), willingness for patient to undergo desired randomised operative approach (acceptability/concordance), withdrawal of patients (non-concordance), study retention (retention rates), and the usefulness and limitations of outcome measures.

The study outcomes examined will relate to the patient, the surgeon performing the procedure, and also cost of the procedure. Surgeon specific outcomes will include measurement of physical and mental strain encountered during the procedures as assessed by the REBA and NASA-TLX scales. Patient specific outcomes will include quality of life analysis (EQ-5D-5L and MFSI-SF scores), hospital length of stay duration, post-operative complications, conversion to open surgery and pain scores. Assessment of intraoperative theatre team communication will be measured using the Oxford NOTECHS II scale which is a modification of a scale originally used in aviation, but adapted and widely validated for use in surgical contexts. The cost of equipment used during the procedure, the cost of theatre utilisation, and the total cost of the inpatient admission will also be calculated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2025
• Est. primary completion date: September 2025
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age =18 years

• Need for colonic or rectal resectional surgery

• Deemed suitable for minimally invasive surgery

Exclusion Criteria:

• Patients who are unable to consent

• Prisoners

• Patients in need of emergency surgery

• High likelihood of treatment delays caused by randomisation process (e.g. due to lack of operative capacity for one approach)

Related Conditions & MeSH terms

• Colorectal Disorders

Intervention

Procedure:
• Laparoscopic Surgeon
Laparoscopic Arm This cohort of participants will have their procedure completed by a human surgeon.
• Robotic Arm
This cohort of participants will have their procedure completed by the Versius Surgical Robotic System.

Locations

Country	Name	City	State
United Kingdom	Milton Keynes University Hospital	Milton Keynes	Bucks

Sponsors (1)

Lead Sponsor	Collaborator
Joanne Turner

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the operating surgeon ergonomics (physical strain) of laparoscopic and Versius® robotic assisted surgery	body position (physical strain) and cognitive workload (mental strain) assessed using the REBA score	Length of the procedure expected to be between 1-4 hours
Secondary	Measurement of the rate of participant recruitment	Measure the number of participants recruited over the length of time. The units of measurement will be presented on a scale of number of participants over a predetermined length of time	Through study completion, an average of 1 year.
Secondary	Measurement of drop-out (withdrawal) rate of participants	Measure the number of participants who withdrawal (drop out) from the trial. The units of measurement will be presented on a scale of numbers of withdrawals versus time.	Assessed from Day 1 (Randomisation) to date of withdrawal
Secondary	Measurement of the unblinding rate of participants	Measure the number of participants where the treatment is unblinded during the trial. This is measured by the number of participants over the length of time who's treatment is unblinded.	Through study completion, an average of 1 year.
Secondary	Mental strain of surgeon	To compare the operating surgeon mental strain of each approach using the NASA-Task Load Index score	30 minutes maximum completion time per surgeon
Secondary	Health Economics	Explore health economic aspects of each approach via calculation of the entire hospital episode and individual operation (including fixed costs and instrument costs) comparing the cost for cohort using the Versus Surgical Robot versus the human surgeon.	Procedure and recovery inpatient stay per participant expected to be between 1-3 days
Secondary	Satisfaction with life scale	Quality of life units completion of EQ-5D-5L questionnaire post operatively on day 28. Total scores used not sub scales to be reported.	Assessed on Day 28
Secondary	Quality of life scale	Quality of life units completion of MFSI-SF questionnaire post operatively on day 28. Total scores used not sub scales to be reported.	Assessed on Day 28
Secondary	.Pain Scores	Using a uni-dimensional pain score measurement examining the change from baseline.	Days 1, 2, 3 and 28
Secondary	Communication	To compare differences in in-theatre communication assessed from audiovisual footage, using the Oxford NOTECHS II score.	1-4 hours expected for the duration of the procedure