Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study

Recruiting

• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

• Registration Number: NCT06579443
• Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

Brief Summary

To determine if robotic surgery can be performed for inflammatory bowel disease (IBD) patients, to ascertain the optimal robotic set up for multi-quadrant IBD operations and evaluate clinical outcomes in robotic compared to laparoscopic surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-12
• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-27
• Study First Posted: 2024-08-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Aged 18 years or over
• Undergoing IBD surgery using MIS (minimally invasive surgery) techniques
• Histological/radiological evidence of inflammatory bowel disease

Exclusion Criteria

• Planned open surgical approach
• Lacks capacity to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To see if robotic surgery is technically feasible for patients with inflammatory bowel disease measured during intra-operative procedure that includes: estimated blood loss in mL.	12 months
Port placement using position of ports on the abdomen marked in a diagram during surgical procedure.	12 months
Docking of robotic arm in robotic surgery using number of times the docking was done with start and end docking time in HH:MM.	12 months
Operative time using time of surgery performed in HH:MM.	12 months

Trial Locations

Locations (1)

Abhilasha Patel; 🇬🇧 Coventry, West Midlands, United Kingdom