The IUSS Crohn's Study: A Feasibility Study

Study Overview
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Brief Summary
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The aim of this study is to evaluate if an intraoperative protocol for Ultrasound scan (USS) is feasible and safe in patients undergoing elective surgery for ileocolic CD. The results of this study could guide the development of a larger randomised trial.

Detailed Description
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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.

Official Title
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Assessing the Feasibility and Safety of Using Intraoperative Ultrasound in Ileocolic Crohn's Disease - The IUSS Crohn's Feasibility Study

Conditions
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Crohn Disease, Inflammatory Bowel Diseases

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intraoperative USS assessments completed. | Recording the number of intraoperative surgery completed | Day of surgery | 
| Number of adverse events reported during 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. | 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 | 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 | 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 | 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. | 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 | 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. | Annotation of key steps for performance of small bowel intraoperative USS in patients with CD. | 1 year |