Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2019-05-30
2021-03-31
Brief Summary
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The aim of this study is firstly to identify which patient groups benefit from additional testing with MAPLe, and secondly to identify if directed treatment has been achieved.
The study will take place across two NHS trusts, both with specialist pelvic floor services. Participants referred to each trust with FI who meet the inclusion/exclusion criteria will be recruited from designated pelvic floor clinics and referrals for anorectal physiology (ARP). Each participant will undergo routine anorectal physiological assessment with Anal Ultrasound (AUS) and High Resolution Anal Manometry (HRAM) and additional assessment with MAPLe. Participation is complete unless treatment has been advised, these participants will undergo repeat assessment with MAPLe at 6 months. Average participation will be 12 months.
The results will be analysed to identify non-inferiority of MAPLe vs current techniques using Bland Altman method. Regression and correlation studies will be performed to identify which groups have benefited from assessment with MAPLe. An expert panel of specialists in the field of pelvic floor will be convened to determine the clinical utilisation of MAPLe.
Detailed Description
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Referrals to each trust are triaged by the overseeing consultant. Potential participants for the study will be identified. At ASPH suitable referrals will be tracked to a dedicated pelvic floor clinic run by a trial representative with medical training. Participants who meet the inclusion/exclusion criteria will be offered a patient information sheet and given an appointment in a dedicated anorectal physiology session (ARP). At UCLH suitable referrals will be contacted via telephone by the PI, should they wish to enrol they will receive a PIS and given an appointment in a dedicated ARP session. Participants will only be assessed and followed up in their recruiting trust.
All participants will complete an incontinence questionnaire and a quality of life questionnaire. Each participant will attend a designated ARP session. At ASPH this will comprise of the current gold standard, Anal Ultrasound (AUS) and High resolution manometry (HRAM) and additional assessment with MAPLe using a standardised protocol. At UCLH participants will undergo AUS in the radiology department, and HRAM and MAPLe in the GI Physiology unit. Through undertaking all three tests participants will act at their own controls. The results will be made available to their overseeing consultant and discussed at their local MDT. Participant participation will conclude following ARP assessment unless treatment is deemed necessary by their local MDT. These participants will be followed up at 6 months with interval MAPLe assessment and incontinence and quality of life questionnaire.
The results will undergo statistical analysis to determine non-inferiority of MAPLe in assessing FI. For analysis participants will be allocated to the following groups: fistula/chronic perianal conditions, obstetric injury \<12 months, obstetric injury \>12months, neurogenic. Each group will be analysed using symptoms profile and MAPLe results to identify correlation. Comparison of MAPle results pre and post treatment will determine if targeted treatment has been achieved.
An expert panel of pelvic floor specialists will be formed to determine the additional benefit of MAPLe in a clinical context. The panel will consist of 3-6 specialists within the field. To reduce bias, each specialist will be provided with literature on the background of MAPLe and how to analyse the results. The panellists will receive up to date guideline on the management of FI. The panel will be provided with cases and ARP results to answer the following questions:
Question 1: What is the additional benefit of MAPLe?
* Panellists will be provided with clinical history HRAM and AUS results
▪ What is the diagnosis and how will you manage this patient?
* MAPLe results provided
* Has the management changed?
* How beneficial on scale 1-10 has the addition been? Question 2 : HRAM and AUS vs MAPLe and AUS
* Panellists will be provided with a series of paired histories set one with HRAM and AUS results, set two with MAPLe and AUS results
* What is the diagnosis and treatment?
* How confident do you feel in your diagnosis and treatment for set two? Question 3: MAPLe alone
* Panellists will be provided with history and MAPLe results
* What is the diagnosis and treatment?
* Do you feel enough information is provided by the MAPLe to allow for a management plan?
The outcomes of the expert panel will undergo statistical analysis. determine if there is a perceived benefit.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Fistula/chronic perianal conditions
Participants symptomatic of FI with chronic perianal disease
MAPLe
Additional assessment with MAPLe
Obstetric injury <12 months
Participants symptomatic of FI \< 12 months following obstetric injury.
MAPLe
Additional assessment with MAPLe
Obstetric injury >12 months
Participants symptomatic of FI \>12 months following obstetric injury.
MAPLe
Additional assessment with MAPLe
Neurogenic
Participants symptomatic of FI with evidence/history of neurological condition.
MAPLe
Additional assessment with MAPLe
Interventions
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MAPLe
Additional assessment with MAPLe
Eligibility Criteria
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Inclusion Criteria
* Capacity to consent
Exclusion Criteria
* Anal cancer
* Acute/painful perianal disease
18 Years
ALL
No
Sponsors
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University College London Hospitals
OTHER
Responsible Party
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Rachael Weatherburn
Research Fellow
Principal Investigators
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Rachael C Weatherburn, MBChB MRCS
Role: PRINCIPAL_INVESTIGATOR
Research Fellow
Locations
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St Peter's Hospital
Chertsey, Surrrey, United Kingdom
University College Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Rachael C Weatherburn, MBChB, MRCS
Role: primary
Prateesh Trivedi, MBBS, FRCS
Role: backup
Rachael C Weatherburn, MBChB, MRCS
Role: primary
Anton V Emmanuel, BSc,MD,FRCP
Role: backup
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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119731
Identifier Type: -
Identifier Source: org_study_id