Recruiting NCT06579443
Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- 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. [Time frame: 12 months]
- Port placement using position of ports on the abdomen marked in a diagram during surgical procedure. [Time frame: 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. [Time frame: 12 months]
- Operative time using time of surgery performed in HH:MM. [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 6 centers
- University Hospitals Coventry & Warwickshire (UHCW) NHS Trust — Coventry
- Newcastle Hospitals NHS Foundation Trust — Newcastle upon Tyne
- Oxford University Hospitals NHS Foundation Trust — Oxford
- London North West University Healthcare NHS Trust — Harrow
- Guy's and St Thomas NHS Foundation Trust — London
- Chelsea and Westminster Hospital NHS Foundation — London
Identifiers
NCT: NCT06579443 · AP637423