Skip to main content
OpenTrials
Completed

NCT Number: NCT03939117

The IUSS Crohn's Study: A Feasibility Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 6, 2019
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.