VirtuAl Technology to Improve the Management of Perianal Crohn's (VAMP) - PROSPECTIVE

NCT06587646 | Recruiting

• 1 other identifier: 22CR004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Crohn's is an inflammatory condition that can affect any part of the gut. Over half a million people in the UK live with Crohn's disease and about a quarter will develop a fistula near their back passage. A fistula is an abnormal connection between two surfaces of the body. These can be hard to treat causing pain and infection. Surgery is required to control infection and in extreme cases this can lead to incontinence or even formation of a stoma, when the bowel is brought to the skin and waste goes into a bag on the tummy wall. Patients with perianal Crohn's are usually referred to a surgeon by their medical team and subsequently undergo a MRI scan and an examination under anaesthesia (EUA) where abscesses (regions of fluid build-up) will be drained and a seton (plastic sling or suture) inserted through the fistula, or the fistula opened to the skin if this will not affect continence. They are then started on specialist medication by the gastroenterologists (gut doctors). Abscesses or fistulas can be difficult to identify during EUA, leading to ongoing infection and repeat procedures. This causes additional scarring and delays the medical treatment that can allow fistulas to heal. Multiple or incorrectly performed operations can also damage the muscles that help hold stool in the back passage, leading to incontinence. We believe that improving how information is communicated between radiology (who report scans) and surgeons will improve their ability to identify and manage all fistulas and collections at operation. Here is a typical MRI report given to the surgeon by the radiologist: \'There is a low intersphincteric fistula with predicted internal opening in the lower half of the anal canal at dentate line level between 5-6 o'clock that passes in the intersphincteric plane to the anal verge between 5-6 o\'clock.\' This protocol was developed in an era when written communication was really the only way to convey information between specialists. Jargon aside, surgeons face significant difficulty interpreting such written descriptions of a complex 3D structure and using it as a surgical guide. Indeed, a major complaint from surgeons is how difficult it is to get real value from these preoperative MRIs, which cost time and money. With advances in digital technology, we believe this system can be vastly improved. Motilent (a UK SME specialising in technology to improve the management of Crohn\'s Disease) has developed a sophisticated visualisation tool to provide a 3D model of the fistula and surrounding structures, we call this tool Virtual EUA (vEUA), allowing the surgeon to better understand the anatomy of the problem in conjunction with radiology. We are aiming to establish whether vEUA changes the behaviour of colorectal surgeons, increasing confidence in identifying and dealing with fistulas, which will reduce the number of surgical procedures required and improve the quality of care, resulting in a cost saving for the hospital and a much-needed step towards more effective management of perianal Crohn\'s. Any patient taking part in the trial will be randomly allocated to have the 3D model utilised in their care or standard care. We will use pre- and post-surgical patient questionnaires, surgical questionnaires and MRI imaging to establish if vEUA is safe and effective in improving the care of patients with perianal Crohn\'s.

Conditions

Perianal Crohns Disease

Keywords

Perianal Crohn's Disease; 3D imaging; MRI

Outcome Measures

Primary Outcomes (15)

• Clinical disease activity assessment

  Clinical outcome measures will be assessed by Perianal Disease Activity Score (PDAI)

  Enrollment to 3 months post-intervention

• Clinical disease activity assessment

  Clinical outcome measures will be assessed by number of surgical interventions (EUAs) in previous 3 months

  Enrollment to 3 months post-intervention

• Clinical disease activity assessment

  Clinical outcome measures will be assessed by number of antibiotic courses in previous 3 months

  Enrollment to 3 months post-intervention

• Patient reported outcomes

  Inflammatory bowel disease (IBD) specific patient outcome measures will be collected on recruitment and after intervention using The Crohn's Anal Fistula Quality of Life (CAF-QoL) scale

  Enrollment to 3 months post-intervention

• Patient reported outcomes

  Inflammatory bowel disease (IBD) specific patient outcome measures will be collected on recruitment and after intervention using Hospital Anxiety and Depression Scale (HADS)

  Enrollment to 3 months post-intervention

• Patient reported outcomes

  Inflammatory bowel disease (IBD) specific patient outcome measures will be collected on recruitment and after intervention using IBD quality of life (IBDQ) scores

  Enrollment to 3 months post-intervention

• Patient reported outcomes

  Inflammatory bowel disease (IBD) specific patient outcome measures will be collected on recruitment and after intervention using Incontinence (Vaizey / St. Marks) score

  Enrollment to 3 months post-intervention

• Biochemical disease activity monitoring

  Biochemical disease activity will be measured byC-reactive protein (CRP)

  Enrollment to 3 months post-intervention

• Biochemical disease activity monitoring

  Biochemical disease activity will be measured by Faecal calprotectin

  Enrollment to 3 months post-intervention

• Disease control at surgery / surgical success

  To assess disease control at surgery patients will undergo a repeat MRI scan of the pelvis at 4-8 weeks post-procedure to look for undrained collections

  4-8 weeks post-surgery

• Disease control at surgery / surgical success

  To assess disease control at surgery patients will undergo a repeat MRI scan of the pelvis at 4-8 weeks post-procedure to look at the size of any remaining collections or untreated fistula i.e. those not laid open or with a seton in-situ

  4-8 weeks post-surgery

• Disease control at surgery / surgical success

  To assess disease control at surgery patients will undergo a repeat MRI scan and MRI scans will be reviewed by an adjudication radiology / surgical panel to compare the relative successes of standard care and vEUA in achieving disease control.

  4-8 weeks post-surgery

• Clinical disease activity assessment

  Clinical outcome measures will be assessed using Perianal Disease Activity Score (PDAI)

  Enrollment to 3 months post-intervention

• Clinical disease activity assessment

  Clinical outcome measures will be assessed using Number of surgical interventions (EUAs) in previous 3 months

  Enrollment to 3 months post-intervention

• Clinical disease activity assessment

  Clinical outcome measures will be assessed using Number of antibiotic courses in previous 3 months

  Enrollment to 3 months post-intervention

Secondary Outcomes (1)

• Evaluation of surgical confidence and opinion data

  up to 4 weeks pre and up to 4 weeks post-surgical intervention

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Standard care (SC) will be defined as a written MRI report by a qualified radiologist followed by EUA and intervention as per surgeon's findings. Interventions will include one or combinations of: lay open of fistula, insertion of seton into the fistula tract and / or drainage of abscess. This arm is to provide outcome data on standard care for this condition as a comparator to the experimental arm.

Diagnostic Test: Standard Care - Written MRI report

vEUA (Virtual Examination Under Anaesthetic) - 3D MRI imaging

EXPERIMENTAL

vEUA-enhanced care will be defined as having a vEUA performed by the radiologist following a MRI using the same unmodified sequence from the standard care (SC) arm (in addition to a written radiology report). The surgeon will then be given unlimited access to the vEUA interactive report via standard PC hardware. The surgeon will then perform the EUA and intervention as per SC but with the additional insight garnered from the vEUA interactive report. We will also monitor the time taken to mark up and produce the vEUA and compare this to the time taken to produce a standard MRI report. The care in this group will be the same as standard care but with the addition of 3D reconstruction of the MRI scan and review of this by the patient and surgeon.

Diagnostic Test: Virtual Examination under Anaeastehtic - 3D reconstruction imaging

Interventions

Virtual Examination under Anaeastehtic - 3D reconstruction imaging DIAGNOSTIC_TEST

3D reconstruction of MRI imaging and review by patient and surgeon prior to surgical intervention.

vEUA (Virtual Examination Under Anaesthetic) - 3D MRI imaging

Standard Care - Written MRI report DIAGNOSTIC_TEST

A standard written MRI report will be provided to the surgeon and patient prior to surgical intervention.

Standard Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to give informed consent
• Active perianal Crohn's disease as defined by clinical assessment with fistula or abscess formation
• A clinical decision has been taken that surgery is required for perianal disease
• Ages of 18-75

You may not qualify if:

• Inability to consent
• history of Proctectomy,
• absence of a diagnosis of Crohn's disease,
• perianal fistulising disease not secondary to Crohn's disease,
• Rectovaginal fistulas
• Malignant disease
• Significant cardiovascular or respiratory disease
• Neurological or cognitive impairment
• Significant physical disability
• Significant hepatic disease or renal failure
• Subjects currently (or in the last three months) participating in another research project
• Pregnancy or breastfeeding
• If MRI is contraindicated (e.g. pacemaker).
• under 18 years old or over 75 years old

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospital NHS Trust

Nottingham, NG7 2UH, United Kingdom

RECRUITING

Central Study Contacts

Jonathan Paul Evans, MBChB PhD FRCS

CONTACT

+44115 924 9924; nuhnt.researchsponsor@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients randomised to either standard care or a virtual EUA (3D reconstruction imaging) via a computerised randomisation software.

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: July 23, 2024
• Primary Completion (Estimated): July 23, 2026
• Study Completion (Estimated): September 7, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)