Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study (RIDDLE)

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.

Study Overview

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Harrow, United Kingdom, HA1 3UJ
      • London, United Kingdom, SE1 7EH
      • London, United Kingdom, SW10 9NH
    • West Midlands
      • Coventry, West Midlands, United Kingdom, CV2 2DX
      • Newcastle upon Tyne, West Midlands, United Kingdom, NE7 7DN
      • Oxford, West Midlands, United Kingdom, OX3 9DU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing surgery for inflammatory bowel disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months
Port placement using position of ports on the abdomen marked in a diagram during surgical procedure.
Time Frame: 12 months
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
12 months
Operative time using time of surgery performed in HH:MM.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammatory Bowel Diseases

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