Versius or Laparoscopic Colorectal Cancer and Non-cancer Operation Outcomes

NCT ID: NCT05262296

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-12-05

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.

Conditions

Colorectal Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Laparoscopic Surgeon

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

Laparoscopic Surgeon

Intervention Type: PROCEDURE

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

Robotic Arm

Intervention Type: PROCEDURE

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

Interventions

Laparoscopic Surgeon

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

Intervention Type: PROCEDURE

Robotic Arm

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

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joanne Turner

OTHER_GOV

Sponsor Role: lead

Responsible Party

Joanne Turner

Academic Research Coordinator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Barrie Keeler

Role: PRINCIPAL_INVESTIGATOR

Consultant Colorectal Surgeon

Locations

Milton Keynes University Hospital

Milton Keynes, Bucks, United Kingdom

Countries

United Kingdom

References

Dixon F, Vitish-Sharma P, Khanna A, Keeler BD; VOLCANO Trial Group. Robotic assisted surgery reduces ergonomic risk during minimally invasive colorectal resection: the VOLCANO randomised controlled trial. Langenbecks Arch Surg. 2024 Apr 27;409(1):142. doi: 10.1007/s00423-024-03322-y.

Reference Type: DERIVED

PMID: 38676748 (View on PubMed)

Other Identifiers

MKUH-RD-020

Identifier Type: -

Identifier Source: org_study_id