The IUSS Crohn's Study: A Feasibility Study

NCT ID: NCT03939117

Last Updated: 2020-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-19
• Study Completion Date: 2020-03-09

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.

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Portsmouth Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valerio Celentano

Role: PRINCIPAL_INVESTIGATOR

Portsmouth Hospitals NHS Trust

Locations

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, United Kingdom

Countries

United Kingdom

Other Identifiers

PHT/2018/44

Identifier Type: -

Identifier Source: org_study_id