Crohn DiseaseNCT03939117
The IUSS Crohn's Study: A Feasibility Study
An observational study of Crohn Disease and Inflammatory Bowel Diseases, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Inflammatory Bowel Diseases
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jan 2019to 9 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population is adults (18+ years) undergoing elective surgery (i.e. planned operation) for CD affecting the small bowel.
Who may be able to join
- 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
Who cannot join
- Undergoing emergency surgery
- Previous abdominal surgery for CD
- Pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, PO6 3LY
About this study
Official title: Assessing the Feasibility and Safety of Using Intraoperative Ultrasound in Ileocolic Crohn's Disease - The IUSS Crohn's 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.
Read the 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
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intraoperative USS assessments completed.
Recording the number of intraoperative surgery completed
Measured: Day of surgery
Number of adverse events reported during surgery.
Recording the number of adverse events reported during the surgey
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start19 Jan 2019
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Valerio Celentano, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939117
- Sponsor's protocol ID
- PHT/2018/44
- Status last verified
- Jun 2020
- First submitted
- 26 Mar 2019
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility and Safety of Using Intraoperative Ultrasound in Ileocolic Crohn's Disease - The IUSS Crohn's Feasibility Study
- ClinicalTrials.gov ID
- NCT03939117
- Acronym / sponsor ID
- PHT/2018/44
- Conditions
- Crohn Disease, Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is adults (18+ years) undergoing elective surgery (i.e. planned operation) for CD affecting the small bowel.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Undergoing emergency surgery
- Previous abdominal surgery for CD
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of intraoperative USS assessments completed.
Time frame: Day of surgery
Recording the number of intraoperative surgery completed
Number of adverse events reported during surgery.
Time frame: Day of surgery
Recording the number of adverse events reported during the surgey
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
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
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
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
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
Related trials for Crohn Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
RecruitingPhase 3
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Crohn Disease, Colitis, Ulcerative
Active, not recruitingPhase 4
Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
Crohn Disease
RecruitingPhase 2
NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
Fibrostenotic Crohn's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerio Celentano principal investigator
Portsmouth Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Inflammatory Bowel Diseases, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of intraoperative USS assessments completed. (time frame: Day of surgery). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.