Inflammatory Bowel DiseasesRIDDLENCT06579443
Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by University Hospitals Coventry and Warwickshire NHS Trust at 6 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- How many people
- 100 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 12 Jul 2024to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery for inflammatory bowel disease
Who may be able to join
- Aged 18 years or over
- Undergoing IBD surgery using MIS (minimally invasive surgery) techniques
- Histological/radiological evidence of inflammatory bowel disease
Who cannot join
- Planned open surgical approach
- Lacks capacity to provide informed consent
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United Kingdom6 sites, 6 recruiting
- Recruiting
University Hospitals Coventry & Warwickshire (UHCW) NHS Trust
Coventry, West Midlands, CV2 2DX
Abhilasha Patel, 02476 966097, abhilasha.patel@uhcw.nhs.uk
Manreet Thind, 02476966581, Riddlestudyoffice@uchw.nhs.uk
- Recruiting
London North West University Healthcare NHS Trust
Harrow, HA1 3UJ
Abhilasha Patel, 02476 966581, abhilasha.patel@uhcw.nhs.uk
Manreet Thind, 02476966581, Riddlestudyoffice@uchw.nhs.uk
- Recruiting
Guy's and St Thomas NHS Foundation Trust
London, SE1 7EH
Abhilasha Patel, 02476 966581, abhilasha.patel@uhcw.nhs.uk
Manreet Thind, 02476966581, Riddlestudyoffice@uchw.nhs.uk
- Recruiting
Chelsea and Westminster Hospital NHS Foundation
London, SW10 9NH
Abhilasha Patel, 02476 966581, abhilasha.patel@uhcw.nhs.uk
Manreet Thind, 02476966581, Riddlestudyoffice@uchw.nhs.uk
- Recruiting
Newcastle Hospitals NHS Foundation Trust
Newcastle upon Tyne, West Midlands, NE7 7DN
Abhilasha Patel, 02476 966581, abhilasha.patel@uhcw.nhs.uk
Manreet Thind, 02476966581, Riddlestudyoffice@uchw.nhs.uk
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, West Midlands, OX3 9DU
Abhilasha Patel, 02476 966581, abhilasha.patel@uhcw.nhs.uk
Manreet Thind, 02476966581, Riddlestudyoffice@uchw.nhs.uk
About this study
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.
- Keywords
- Robotic IBD surgery, Laparoscopic IBD surgery
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Port placement using position of ports on the abdomen marked in a diagram during surgical procedure.
Measured: 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.
Measured: 12 months
Operative time using time of surgery performed in HH:MM.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start12 Jul 2024
- Primary completionNov 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579443
- Sponsor's protocol ID
- AP637423
- Acronym
- RIDDLE
- Status last verified
- Oct 2026
- First submitted
- 23 Aug 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study
- ClinicalTrials.gov ID
- NCT06579443
- Acronym / sponsor ID
- RIDDLE / AP637423
- Keywords
- Robotic IBD surgery, Laparoscopic IBD surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery for inflammatory bowel disease
Key inclusion criteria (3 listed)
- Aged 18 years or over
- Undergoing IBD surgery using MIS (minimally invasive surgery) techniques
- Histological/radiological evidence of inflammatory bowel disease
Key exclusion criteria (2 listed)
- Planned open surgical approach
- Lacks capacity to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by University Hospitals Coventry and Warwickshire NHS Trust at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manreet Thind (02476966581, Riddlestudyoffice@uchw.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.