Clinical trial NCT05262296: Versius or Laparoscopic Colorectal Cancer and Non-cancer Operation Outcomes
Official title: A Single Blinded Randomised Controlled Trial Comparing the Ergonomics of Laparoscopic and Versius Robotic Assisted Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Disorders
Keywords: robotic surgery
laparoscopic surgery
ergonomics
Versius
Lead sponsor: Milton Keynes University Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2022-03-02
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who require surgery to remove part or all of the colon or rectum will be approached to participate in the trial.

In this trial, all patients will be only be considered if deemed suitable for surgery via a minimally invasive approach

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: To compare the operating surgeon ergonomics (physical strain) of laparoscopic and Versius® robotic assisted surgery
timeFrame: Length of the procedure expected to be between 1-4 hours
Secondary outcomes:
measure: Measurement of the rate of participant recruitment
timeFrame: Through study completion, an average of 1 year.
measure: Measurement of drop-out (withdrawal) rate of participants
timeFrame: Assessed from Day 1 (Randomisation) to date of withdrawal
measure: Measurement of the unblinding rate of participants
timeFrame: Through study completion, an average of 1 year.
measure: Mental strain of surgeon
timeFrame: 30 minutes maximum completion time per surgeon
measure: Health Economics
timeFrame: Procedure and recovery inpatient stay per participant expected to be between 1-3 days
measure: Satisfaction with life scale
timeFrame: Assessed on Day 28
measure: Quality of life scale
timeFrame: Assessed on Day 28
measure: .Pain Scores
timeFrame: Days 1, 2, 3 and 28
measure: Communication
timeFrame: 1-4 hours expected for the duration of the procedure
Other outcomes:
Locations:
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes University Hospital
state: Bucks
Study officials:
affiliation: Consultant Colorectal Surgeon
name: Barrie Keeler
role: PRINCIPAL_INVESTIGATOR
References: