Clinical trial NCT03939117: The IUSS Crohn's Study: A Feasibility Study
Official title: Assessing the Feasibility and Safety of Using Intraoperative Ultrasound in Ileocolic Crohn's Disease - The IUSS Crohn's Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Inflammatory Bowel Diseases
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2019-05-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of intraoperative USS assessments completed.
timeFrame: Day of surgery
measure: Number of adverse events reported during surgery.
timeFrame: Day of surgery
measure: 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.
timeFrame: Day of surgery
measure: To record the length of areas affected by crohn's disease identified at macroscopic intraoperative assessment of the small bowel by the surgeon
timeFrame: Day of surgery
measure: To compare the incidence of crohn's disease indentified macroscopically by the surgeon with the intraoperative ultrasound assessment
timeFrame: Day of surgery
measure: To compare the length of crohn's disease identified marcoscopically by the surgeon with the intraoperative ultrasound assessment
timeFrame: Day of surgery
measure: To evaluate the feasibility of study delivery, i.e. recruitment of study participants and retention at follow-up visits.
timeFrame: 6 week follow up
measure: To record surgical and patient outcomes up to 6 weeks
timeFrame: 30 day morbidity
measure: To evaluate the direct and indirect costs of a standardised intraoperative USS protocol.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
state: Hampshire
Study officials:
affiliation: Portsmouth Hospitals NHS Trust
name: Valerio Celentano
role: PRINCIPAL_INVESTIGATOR
References: