- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03939117
The IUSS Crohn's Study: A Feasibility Study
Assessing the Feasibility and Safety of Using Intraoperative Ultrasound in Ileocolic Crohn's Disease - The IUSS Crohn's Feasibility Study
Study Overview
Status
Conditions
Detailed Description
To date the intraoperative clinical assessment of location and extent of ileocolic CD has been left at the discretion of the operating surgeon guided by a mixture of experience, tactile feedback, macroscopic appearance and results of preoperative imaging, with significant intra and inter surgeon variability, potentially resulting in long segments of small bowel being removed unnecessarily, which is a significant concern in patients at risk of several abdominal surgeries and of developing "short bowel syndrome". At surgery, the operating surgeon also evaluates the full length of the small bowel to locate and assess further areas of CD: a process called "disease mapping". This process is not only important to intervene simultaneously on other CD segments causing complications, but also to provide the IBD MDT team with a full evaluation of the extent and severity of CD in that particular patient, in order to guide the tailored postoperative maintenance treatment.
A standardised approach to intraoperative evaluation of extent and location of CD is desirable, based on reliable and reproducible techniques, minimising the risk of surgical recurrence, optimising the decision making on maintenance treatment and follow-up, protecting patients from unnecessary extended small bowel resections and risk of short bowel syndrome.
The study objectives are To evaluate the feasibility of using intraoperative USS in patients with CD of the small bowel, and to describe the steps of the procedure.
To assess safety of the intraoperative USS procedure during surgery. To evaluate the feasibility of study delivery, i.e. recruitment of study participants and retention at follow-up visits.
To record surgical and patient outcomes up to 6 weeks To evaluate the direct and indirect costs of a standardised intraoperative USS protocol.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Hampshire
-
Portsmouth, Hampshire, United Kingdom, PO6 3LY
- Portsmouth Hospitals NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 18 years or over
- American society of Anaesthesiologists (ASA) grade I, II or III
- Undergoing elective surgery to remove part of the terminal ileum which is affected by CD.
- . Indication for surgery agreed at IBD MDT meeting
- Able to give written informed consent
Exclusion Criteria:
- Undergoing emergency surgery
- Previous abdominal surgery for CD
- Pregnant
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of intraoperative USS assessments completed.
Time Frame: Day of surgery
|
Recording the number of intraoperative surgery completed
|
Day of surgery
|
Number of adverse events reported during surgery.
Time Frame: Day of surgery
|
Recording the number of adverse events reported during the surgey
|
Day of surgery
|
To record the incidence of crohn's disease identified at macroscopic intraoperative assessment of the small bowel by the surgeon, and the intraoperative USS assessment of the small bowel.
Time Frame: Day of surgery
|
recording the incidence of crohn's disease identified following assessment of the small bowel by the surgeon macroscopcially
|
Day of surgery
|
To record the length of areas affected by crohn's disease identified at macroscopic intraoperative assessment of the small bowel by the surgeon
Time Frame: Day of surgery
|
Measurement in centimeters of the length of bowel affected by crohn's disease as identified by the surgeon macroscopically
|
Day of surgery
|
To compare the incidence of crohn's disease indentified macroscopically by the surgeon with the intraoperative ultrasound assessment
Time Frame: Day of surgery
|
compare the incidence of crohn's disease identified by the surgeon with the incidence of crohn's disease identified by the intraoperative ultrasound assessment
|
Day of surgery
|
To compare the length of crohn's disease identified marcoscopically by the surgeon with the intraoperative ultrasound assessment
Time Frame: Day of surgery
|
compare the length of crohn's disease in centimetres identified by the surgeon with the incidence of crohn's disease identified by the intraoperative ultrasound assessment
|
Day of surgery
|
To evaluate the feasibility of study delivery, i.e. recruitment of study participants and retention at follow-up visits.
Time Frame: 6 week follow up
|
Feasibility of data collection required for a future trial measured by number of eligible participants, the proportion of patients consenting for the study, the proportion of recruited participants with all the required baseline and follow-up assessments completed, proportion of withdrawals from follow-up data collection, reasons for withdrawal and number of losses to follow-up.
|
6 week follow up
|
To record surgical and patient outcomes up to 6 weeks
Time Frame: 30 day morbidity
|
Operating time (Kaplan-Meier analysis), intra- and post-operative complication rates, 30 day morbidity and mortality rate
|
30 day morbidity
|
To evaluate the direct and indirect costs of a standardised intraoperative USS protocol.
Time Frame: 1 year
|
Annotation of key steps for performance of small bowel intraoperative USS in patients with CD.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Valerio Celentano, Portsmouth Hospitals NHS Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHT/2018/44
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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