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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

The IUSS Crohn's Study: A Feasibility Study

Clinicaltrials.gov identifier NCT03939117

Recruitment Status Completed

First Posted May 6, 2019

Last update posted June 22, 2020

Study Description

Brief summary:

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.

  • Condition or Disease:Crohn Disease
    Inflammatory Bowel Diseases
  • Intervention/Treatment:
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Actual Enrollment: 6 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Assessing the Feasibility and Safety of Using Intraoperative Ultrasound in Ileocolic Crohn's Disease - The IUSS Crohn's Feasibility Study
  • Actual Study Start Date: January 2019
  • Actual Primary Completion Date: March 2020
  • Actual Study Completion Date: March 2020
Outcome Measures
  • Primary Outcome Measures: 1. Number of intraoperative USS assessments completed. [ Time Frame: Day of surgery ]
    Recording the number of intraoperative surgery completed
  • 2. Number of adverse events reported during surgery. [ Time Frame: Day of surgery ]
    Recording the number of adverse events reported during the surgey
  • 3. 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
  • 4. 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
  • 5. 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
  • 6. 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
  • 7. 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.
  • 8. 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
  • 9. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: The target population is adults (18+ years) undergoing elective surgery (i.e. planned operation) for CD affecting the small bowel.
Criteria

Inclusion Criteria:

1. Aged 18 years or over

2. American society of Anaesthesiologists (ASA) grade I, II or III

3. Undergoing elective surgery to remove part of the terminal ileum which is affected by
CD.

4. . Indication for surgery agreed at IBD MDT meeting

5. Able to give written informed consent

Exclusion Criteria:

1. Undergoing emergency surgery

2. Previous abdominal surgery for CD

3. Pregnant

Contacts and Locations
Contacts
Locations

United Kingdom, Hampshire
Portsmouth Hospitals NHS Trust
Portsmouth

Sponsors and Collaborators

Portsmouth Hospitals NHS Trust

Investigators

Principal Investigator: Valerio Celentano Portsmouth Hospitals NHS Trust

More Information
  • Responsible Party: Portsmouth Hospitals NHS Trust
  • ClinicalTrials.gov Identifier: NCT03939117 History of Changes
  • Other Study ID Numbers: PHT/2018/44
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: June 22, 2020
  • Last Verified: June 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Crohn Disease Inflammatory Bowel Diseases