NCT05262296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2024

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

2.3 years

First QC Date

February 21, 2022

Last Update Submit

March 10, 2025

Conditions

Colorectal Disorders

Keywords

robotic surgerylaparoscopic surgeryergonomicsVersius

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Measurement of the rate of participant recruitment

    Through study completion, an average of 1 year.

  • Measurement of drop-out (withdrawal) rate of participants

    Assessed from Day 1 (Randomisation) to date of withdrawal

  • Measurement of the unblinding rate of participants

    Through study completion, an average of 1 year.

  • Mental strain of surgeon

    30 minutes maximum completion time per surgeon

  • Health Economics

    Procedure and recovery inpatient stay per participant expected to be between 1-3 days

  • +4 more secondary outcomes

Study Arms (2)

Laparoscopic Surgeon

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

Procedure: Laparoscopic Surgeon

Robotic Arm

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

Procedure: Robotic Arm

Interventions

Laparoscopic SurgeonPROCEDURE

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

Laparoscopic Surgeon
Robotic ArmPROCEDURE

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

Robotic Arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Age ≥18 years
  • Need for colonic or rectal resectional surgery
  • Deemed suitable for minimally invasive surgery

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Milton Keynes University Hospital

Milton Keynes, Bucks, MK6 5LD, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 38676748DERIVED

Study Officials

  • Barrie Keeler

    Consultant Colorectal Surgeon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Academic Research Coordinator

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 2, 2022

Study Start

August 1, 2022

Primary Completion

December 5, 2024

Study Completion

December 5, 2024

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)