This cohort of participants will have their procedure completed by a human surgeon.

This cohort of participants will have their procedure completed by the Versius Surgical Robotic System

Laparoscopic Arm This cohort of participants will have their procedure completed by a human surgeon.

Laparoscopic Surgeon

This cohort of participants will have their procedure completed by the Versius Surgical Robotic System.

Robotic Arm

Joanne Turner

Antoanela Colda

Barrie Keeler

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.

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.

Versius Or Laparoscopic Colorectal Cancer and Non-cancer Operation Outcomes

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

body position (physical strain) and cognitive workload (mental strain) assessed using the REBA score

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

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.

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.

To compare the operating surgeon mental strain of each approach using the NASA-Task Load Index score

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.

Quality of life units completion of EQ-5D-5L questionnaire post operatively on day 28. Total scores used not sub scales to be reported.

Quality of life units completion of MFSI-SF questionnaire post operatively on day 28. Total scores used not sub scales to be reported.

Using a uni-dimensional pain score measurement examining the change from baseline.

To compare differences in in-theatre communication assessed from audiovisual footage, using the Oxford NOTECHS II score.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Versius Or Laparoscopic Colorectal Cancer and Non-cancer Operation Outcomes	NCT05262296	Colorectal Diso...	Laparoscopic Su... Robotic Arm	18 Years - 100 Years	Milton Keynes University Hospital NHS Foundation Trust
Versius Or Laparoscopic Colorectal Cancer and Non-cancer Operation Outcomes	NCT05262296	Colorectal Diso...	Laparoscopic Su... Robotic Arm	18 Years - 100 Years	Milton Keynes University Hospital NHS Foundation Trust

Spots Global Cancer Trial Database for laparoscopic surgeon