The IUSS Crohn's Study: A Feasibility Study

NCT03939117 | Completed

• 1 other identifier: PHT/2018/44
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (9)

• Number of intraoperative USS assessments completed.

  Recording the number of intraoperative surgery completed

  Day of surgery

• Number of adverse events reported during surgery.

  Recording the number of adverse events reported during the surgey

  Day of surgery

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Undergoing emergency surgery
• Previous abdominal surgery for CD
• Pregnant

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Valerio Celentano

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: May 6, 2019
• Study Start: January 19, 2019
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: June 22, 2020

Record last verified: 2020-06

Locations

GB (1)