Versius or Laparoscopic Abdominal Hernia REpair

NCT ID: NCT05253586

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2024-03-31

Brief Summary

This trial will compare laparoscopic and robotic-assisted abdominal 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.

Detailed Description

This study has been designed to assess the ergonomics of Versius® assisted surgery in comparison with laparoscopic surgery in the management of abdominal hernias. The study will randomise 60 patients who require repair of an abdominal hernia and have been deemed suitable for a minimally invasive approach. 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.

Conditions

Abdominal Hernia; Abdominal Surgery

Study Design

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

Study Groups

Laparoscopic Arm

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

Laparoscopic

Intervention Type: PROCEDURE

Surgeon

Robotic Arm

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

Robotic

Intervention Type: PROCEDURE

Versius system

Interventions

Laparoscopic

Surgeon

Intervention Type: PROCEDURE

Robotic

Versius system

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• Need for abdominal hernia repair surgery

• Incisional
• Congenital
• Deemed suitable for minimally invasive surgery

Exclusion Criteria

• Patients who are unable to consent
• Prisoners
• Patients in need of emergency surgery
• Patients with a hernial defect size of over 7cm

• 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

Other Identifiers

MKUH-RD-019

Identifier Type: -

Identifier Source: org_study_id