NCT06579443

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

December 10, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

August 23, 2024

Last Update Submit

December 2, 2025

Conditions

Keywords

Robotic IBD surgeryLaparoscopic IBD surgery

Outcome Measures

Primary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgery for inflammatory bowel disease

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University Hospitals Coventry & Warwickshire (UHCW) NHS Trust

Coventry, West Midlands, CV2 2DX, United Kingdom

RECRUITING

Newcastle Hospitals NHS Foundation Trust

Newcastle upon Tyne, West Midlands, NE7 7DN, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, West Midlands, OX3 9DU, United Kingdom

RECRUITING

London North West University Healthcare NHS Trust

Harrow, HA1 3UJ, United Kingdom

RECRUITING

Guy's and St Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

Chelsea and Westminster Hospital NHS Foundation

London, SW10 9NH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2024

First Posted

August 30, 2024

Study Start

July 12, 2024

Primary Completion

May 1, 2026

Study Completion

June 1, 2026

Last Updated

December 10, 2025

Record last verified: 2025-03

Locations