Versius or Laparoscopic TransAbdominal Inguinal Hernia REpair

NCT05262374 | Completed DMC

• 1 other identifier: MKUH-RD-021
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will compare laparoscopic and robotic-assisted inguinal hernia repairs, using the Versius® system. We will initially aim to recruit 60 patients (20 patients in the laparoscopic arm and 40 in the robotic arm) in order to assess the ergonomic impact of each modality on the operating surgeon. This aims to provide in vivo information on whether robotic surgery provides any advantages to the operating surgeon. This trial will also be used to assess the feasibility of recruitment to a future larger study, and any data collected will be used as pilot data.

Conditions

Inguinal Hernia

Keywords

surgery; ergonomics; robotics

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 (10)

• 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.

Study Arms (2)

Laparoscopic Arm

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

Procedure: Procedure/Surgery: Laparoscopic

Robotic Arm

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

Procedure: Robotic

Interventions

Procedure/Surgery: Laparoscopic PROCEDURE

Surgeon

Laparoscopic Arm

Robotic PROCEDURE

Versius system.

Robotic Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who require surgery to repair an inguinal hernia 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 inguinal hernia repair 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
• Patients with inguinoscrotal or recurrent inguinal hernias

Sponsors & Collaborators

• Milton Keynes University Hospital NHS Foundation Trust: lead

Study Sites (1)

Surgical Division

Milton Keynes, United Kingdom

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Laparoscopy; Robotics

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Barrie Keeler

  Colorectal surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: February 9, 2023
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)