The IUSS Crohn's Study: A Feasibility Study

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939117
• Other study ID #: PHT/2018/44
• Status: Completed
• Start date: January 19, 2019
• Est. completion date: March 9, 2020

Study information

• Verified date: June 2020
• Source: Portsmouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 9, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals NHS Trust	Portsmouth	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of intraoperative USS assessments completed.	Recording the number of intraoperative surgery completed	Day of surgery
Primary	Number of adverse events reported during surgery.	Recording the number of adverse events reported during the surgey	Day of surgery
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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