An observational study in Crohn Disease and Inflammatory Bowel Diseases, sponsored by Portsmouth Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-22.
Sponsored by Portsmouth Hospitals NHS Trust · Observational
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.
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 6 is below the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Portsmouth Hospitals NHS Trust is the lead sponsor of 74 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The target population is adults (18+ years) undergoing elective surgery (i.e. planned operation) for CD affecting the small bowel.
Exclusion Criteria:
Number of intraoperative USS assessments completed.
Recording the number of intraoperative surgery completed
Time frame: Day of surgery
Number of adverse events reported during surgery.
Recording the number of adverse events reported during the surgey
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 1 year
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Portsmouth Hospitals NHS Trust