Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587646
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
VirtuAl Technology to Improve the Management of Perianal Crohn39s VAMP - PROSPECTIVE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Feasibility Study to Assess a 34Virtual34 vEUA Technology to Improve the Management of Perianal Crohn39s Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAMP-PROSPECT
Brief Summary:
Crohns is an inflammatory condition that can affect any part of the gut Over half a million people in the UK live with Crohns 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 Crohns 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
39There is a low intersphincteric fistula with predicted internal opening in the lower half of the anal canal at dentate line level between 5-6 oclock that passes in the intersphincteric plane to the anal verge between 5-6 o39clock39
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 Crohnamp39s 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 Crohn39s
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 Crohn39s
Patients with perianal Crohns 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
39There is a low intersphincteric fistula with predicted internal opening in the lower half of the anal canal at dentate line level between 5-6 oclock that passes in the intersphincteric plane to the anal verge between 5-6 o39clock39
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 Crohnamp39s 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 Crohn39s
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 Crohn39s
Detailed Description:
The development of the vEUA tool is a significant advancement in the management of perianal Crohn39s disease fistulas Mismanagement of fistulas can lead to significant complications such as abscesses scarring and delayed healing Additionally multiple surgeries can cause damage to the anal sphincter muscles leading to incontinence and other issues
With the vEUA tool surgeons can now have a more precise and accurate understanding of the fistula anatomy before conducting the examination under anaesthesia This approach can significantly reduce the risk of misdiagnosis and subsequent complications The tools 3D visualization capability allows surgeons to assess the extent of the fistula its location and any associated abscesses or inflammation This information is essential for planning the surgery and ensuring that the procedure is as minimally invasive as possible
In addition to improving surgical planning the vEUA tool can also enhance post-operative care The 3D model generated by the tool can be used to monitor the healing process and ensure that the fistula has healed correctly This approach reduces the need for multiple follow-up surgeries and promotes faster healing With the vEUA tool surgeons can better plan the surgery to avoid damaging the muscles promoting faster healing and reducing the risk of long-term complications
Overall the development of the vEUA tool represents a significant breakthrough in the management of Crohn39s disease and perianal fistulas The toolamp39s ability to provide a more precise and accurate understanding of the fistulaamp39s anatomy will reduce the risk of misdiagnosis promote faster healing and improve patient outcomes
vEUA generates a disease activity score based on T2 enhancement and a volumetric measurement of the fistula tract providing a more detailed analysis of the fistula and surrounding structures
RESEARCH QUESTION AIMS Our proposed investigation aims to generate early clinical usage data to assess the feasibility of the vEUA approach Our findings will feed into a larger multicentre study at a later date
In this early-stage investigation we aim to answer the question
Does vEUA improve the surgeons confidence in and ability to manage all fistula tracts and drain all collections in perianal Crohns disease at surgery
In addition we aim to gain insight into the following supplementary questions that will feed into future projects
Can vEUA be used effectively by trained radiologists
How long does it take a radiologist to perform a vEUA
What concerns do patients have over the vEUA system How does viewing a vEUA report change their perception of their disease their treatment and their ability to provide informed consent Answered through our PPIE work packages and survey
Is there any indication that the vEUA system reduces the likelihood of a patient requiring multiple operations to control sepsis and fistula tracts
Does the use of vEUA translate to improved disease control and a subsequent improvement in quality of life for patients
The purpose of answering these questions is to determine whether the quality of care afforded to perianal Crohn39s patients can be meaningfully improved by the vEUA system These data will highlight which patients will benefit most from vEUA It is possible that this technology will be most useful for those with more complex disease ie multiple fistula tracts or deep collections thus ensuring value for money in the future through correct patient selection to vEUA
30 patients will be prospectively recruited to this vEUA feasibility study 15 to standard care and 15 randomised to the vEUA technology and assess outcome data as outlined below to guide future studies and assess the acceptability of the vEUA technology to patients and clinicians
Standard care SC will be defined as a written MRI report by a qualified radiologist followed by EUA and intervention as per surgeons findings Interventions will include one or combinations of lay open of fistula insertion of seton into the fistula tract and or drainage of abscess
vEUA-enhanced care will be defined as having a vEUA performed by the radiologist following a MRI using the same unmodified sequence from the 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
OUTCOME MEASURES
These will include
1 Baseline inflammatory bowel disease IBD specific patient outcome measures will be collected on recruitment including
IBD quality of life IBDQ scores
The Crohns Anal Fistula Quality of Life CAF-QoL scale
Hospital Anxiety and Depression Scale HADS
Incontinence Vaizey St Marks score
2 Baseline clinical outcome measures will be assessed including
Perianal Disease Activity Score PDAI
Number of surgical interventions EUAs in previous 3 months
Number of antibiotic courses in previous 3 months
3 Biochemical disease activity will be measured by
C-reactive protein CRP
Faecal calprotectin These outcome measures will be re-captured again at 3 months postoperatively and exploratory analyses will be undertaken We will use baseline variables to predict postoperative response
4 An evaluation of surgical confidence and opinion will be used to assess surgical confidence prior to commencement of the procedure surgeons will be asked to propose and document a likely pre-operative plan based on their understanding of the anatomy of the disease from the information available through either a standard MRI report or vEUA Their confidence in this plan will be scored using a Likert scale from 1 no confidence to 10 extremely confident Immediately following surgery surgeons will again be asked to complete a questionnaire to include interventions completed adherence to pre-operative plan scored from 1 no adherence to plan to 10 exact plan followed and their confidence in having adequately and safely identified and treated all fistula and collections with each aspect scored from 1 no confidence to 10 extremely confident
5 An evaluation of patient opinion will help us understand the benefit of vEUA in describing and explaining disease anatomy to the patient and in obtaining informed consent for surgical intervention Patients will be presented with a decisional conflict scale10 to evaluate their personal uncertainty related to their surgery after consultation with a surgeon A 16-question 5-response category strongly disagree to strongly agree traditional decisional conflict scale will be to assess whether the patient feels they are making an effective decision ie the decision is informed values-based and likely to be implemented Results will be compared between patients shown their vEUA and those randomised to SC
6 A radiological assessment of surgical quality will allow assessment of disease control at surgery Patients will undergo a repeat MRI scan of the pelvis at 4 weeks post-procedure to look for undrained collections the size of any remaining collections or untreated fistula ie those not laid open or with a seton in-situ MRI scans will be reviewed by an adjudication radiology surgical panel to compare the relative successes of SC and vEUA in achieving disease control
We hope to establish utilising these data that vEUA is safe and effective in improving the care of patients with perianal Crohn39s
With the vEUA tool surgeons can now have a more precise and accurate understanding of the fistula anatomy before conducting the examination under anaesthesia This approach can significantly reduce the risk of misdiagnosis and subsequent complications The tools 3D visualization capability allows surgeons to assess the extent of the fistula its location and any associated abscesses or inflammation This information is essential for planning the surgery and ensuring that the procedure is as minimally invasive as possible
In addition to improving surgical planning the vEUA tool can also enhance post-operative care The 3D model generated by the tool can be used to monitor the healing process and ensure that the fistula has healed correctly This approach reduces the need for multiple follow-up surgeries and promotes faster healing With the vEUA tool surgeons can better plan the surgery to avoid damaging the muscles promoting faster healing and reducing the risk of long-term complications
Overall the development of the vEUA tool represents a significant breakthrough in the management of Crohn39s disease and perianal fistulas The toolamp39s ability to provide a more precise and accurate understanding of the fistulaamp39s anatomy will reduce the risk of misdiagnosis promote faster healing and improve patient outcomes
vEUA generates a disease activity score based on T2 enhancement and a volumetric measurement of the fistula tract providing a more detailed analysis of the fistula and surrounding structures
RESEARCH QUESTION AIMS Our proposed investigation aims to generate early clinical usage data to assess the feasibility of the vEUA approach Our findings will feed into a larger multicentre study at a later date
In this early-stage investigation we aim to answer the question
Does vEUA improve the surgeons confidence in and ability to manage all fistula tracts and drain all collections in perianal Crohns disease at surgery
In addition we aim to gain insight into the following supplementary questions that will feed into future projects
Can vEUA be used effectively by trained radiologists
How long does it take a radiologist to perform a vEUA
What concerns do patients have over the vEUA system How does viewing a vEUA report change their perception of their disease their treatment and their ability to provide informed consent Answered through our PPIE work packages and survey
Is there any indication that the vEUA system reduces the likelihood of a patient requiring multiple operations to control sepsis and fistula tracts
Does the use of vEUA translate to improved disease control and a subsequent improvement in quality of life for patients
The purpose of answering these questions is to determine whether the quality of care afforded to perianal Crohn39s patients can be meaningfully improved by the vEUA system These data will highlight which patients will benefit most from vEUA It is possible that this technology will be most useful for those with more complex disease ie multiple fistula tracts or deep collections thus ensuring value for money in the future through correct patient selection to vEUA
30 patients will be prospectively recruited to this vEUA feasibility study 15 to standard care and 15 randomised to the vEUA technology and assess outcome data as outlined below to guide future studies and assess the acceptability of the vEUA technology to patients and clinicians
Standard care SC will be defined as a written MRI report by a qualified radiologist followed by EUA and intervention as per surgeons findings Interventions will include one or combinations of lay open of fistula insertion of seton into the fistula tract and or drainage of abscess
vEUA-enhanced care will be defined as having a vEUA performed by the radiologist following a MRI using the same unmodified sequence from the 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
OUTCOME MEASURES
These will include
1 Baseline inflammatory bowel disease IBD specific patient outcome measures will be collected on recruitment including
IBD quality of life IBDQ scores
The Crohns Anal Fistula Quality of Life CAF-QoL scale
Hospital Anxiety and Depression Scale HADS
Incontinence Vaizey St Marks score
2 Baseline clinical outcome measures will be assessed including
Perianal Disease Activity Score PDAI
Number of surgical interventions EUAs in previous 3 months
Number of antibiotic courses in previous 3 months
3 Biochemical disease activity will be measured by
C-reactive protein CRP
Faecal calprotectin These outcome measures will be re-captured again at 3 months postoperatively and exploratory analyses will be undertaken We will use baseline variables to predict postoperative response
4 An evaluation of surgical confidence and opinion will be used to assess surgical confidence prior to commencement of the procedure surgeons will be asked to propose and document a likely pre-operative plan based on their understanding of the anatomy of the disease from the information available through either a standard MRI report or vEUA Their confidence in this plan will be scored using a Likert scale from 1 no confidence to 10 extremely confident Immediately following surgery surgeons will again be asked to complete a questionnaire to include interventions completed adherence to pre-operative plan scored from 1 no adherence to plan to 10 exact plan followed and their confidence in having adequately and safely identified and treated all fistula and collections with each aspect scored from 1 no confidence to 10 extremely confident
5 An evaluation of patient opinion will help us understand the benefit of vEUA in describing and explaining disease anatomy to the patient and in obtaining informed consent for surgical intervention Patients will be presented with a decisional conflict scale10 to evaluate their personal uncertainty related to their surgery after consultation with a surgeon A 16-question 5-response category strongly disagree to strongly agree traditional decisional conflict scale will be to assess whether the patient feels they are making an effective decision ie the decision is informed values-based and likely to be implemented Results will be compared between patients shown their vEUA and those randomised to SC
6 A radiological assessment of surgical quality will allow assessment of disease control at surgery Patients will undergo a repeat MRI scan of the pelvis at 4 weeks post-procedure to look for undrained collections the size of any remaining collections or untreated fistula ie those not laid open or with a seton in-situ MRI scans will be reviewed by an adjudication radiology surgical panel to compare the relative successes of SC and vEUA in achieving disease control
We hope to establish utilising these data that vEUA is safe and effective in improving the care of patients with perianal Crohn39s
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None