Plain English Summary
Background and study aims
Sphinkeeper is a new artificial anal sphincter designed for the treatment of faecal incontinence. Faecal incontinence (inability to hold your stools) is a debilitating condition, which often occurs due to the sphincters in the bottom not working properly. Sphinkeeper surgery involves implanting specifically designed self-expandable implants into the bottom, essentially creating a doughnut which acts like a new strong, artificial bottom sphincter. Its use has been approved in the UK for patients with faecal incontinence and patients currently are already benefiting from its application. There is a need to collect long-term data on the faecal incontinence results as well as the surgery results and complications of the patients receiving Sphinkeeper treatment. The aim is to record the data of all patients receiving this treatment. This is because we need to know how effective this treatment is.
Who can participate?
All patients receiving Sphinkeeper surgery for faecal incontinence
What does the study involve?
Patients participating in this study will have their faecal incontinence assessed by filling in questionnaires before surgery and after surgery in three time periods:
1. The period immediately after surgery (1-30 days after surgery)
2. After 6 months
3. After 12 months
What are the possible benefits and risks of participating?
Participation in this study does not pose any benefits or risk to participants, as it only requires completion of questionnaires.
Where is the study run from?
Poole Hospital (lead centre) and 7 other hospitals in the UK
When is the study starting and how long is it expected to run for?
May 2018 to January 2020
Who is funding the study?
Self-funded
Who is the main contact?
Andrew Clarke
andrew.clarke@poole.nhs.uk
Trial website
Contact information
Type
Public
Primary contact
Mr Andrew Clarke
ORCID ID
Contact details
Poole Hospital
Longfleet Road
Poole
BH15 2JB
Poole
BH15 2JB
United Kingdom
+44 (0)1202665511
andrew.clarke@poole.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SK01
Study information
Scientific title
Anal Sphinkeeper in patients with faecal incontinence: a multicentre prospective evaluation of surgical outcomes and faecal incontinence following Sphinkeeper application for patients with faecal incontinence
Acronym
Study hypothesis
Anal Sphinkeeper is a safe and effective method of treating faecal incontinence
Ethics approval
None required. The use of Sphinkeeper for clinical use in the UK has already been approved. This study just aims to collect prospective data on the surgical outcomes and faecal incontinence of patients that receive this treatment.
Study design
Prospective observational case series
Primary study design
Observational
Secondary study design
Case series
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Faecal incontinence
Intervention
Patients participating in this study will be seen in the outpatient department before to discuss Sphinkeeper surgery. During this visit patients will have a full faecal incontinence history, past obstetric history and past gynaecological history taken. Co-morbidities will also will be recorded, along with all previous treatments for faecal incontinence. This will be followed by a detailed baseline faecal incontinence assessment including a faecal incontinence severity score and faecal incontinence quality of life score. Finally, a physical examination will be performed relevant to pelvic floor anatomy and all pre-operative investigations will be recorded. Patients opting for treatment with Sphinkeeper will be consented for their surgery and all their data to be used for the purpose of research routinely either on the pre-operative outpatient clinic or on the day of surgery. Sphinkeeper is a new artificial anal sphincter designed for the minimally invasive treatment of faecal incontinence. It involves implanting specifically designed self-expandable prosthesis into the inter-sphincteric space. Ten prostheses are implanted between the internal and external sphincters essentially creating a shape memory doughnut which acts like a third artificial anal sphincter. Its use has been approved in the UK for patients with faecal incontinence and patients currently are already benefiting from its application. Surgery and peri-operative care will carry on as normal and as per institution protocol. No alterations on the surgical pathway will be made as a result of this study. Relevant intra-operative data will be recorded. Following surgery patients will be followed up routinely three times to have their post-operative function assessed. These will occur at the following time intervals:
1. Immediate post-operative period (1-30 days after surgery)
2. At 6 months
3. At 12 months after surgery
Each clinic appointment is estimated to take between 15-30 minutes. During this period data on faecal incontinence scores will be collected as well as on surgical outcomes and complications. A detailed study proforma with all the data collected can be provided on request. Patient participation will end after the third post-operative follow up appointment at 12 months.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Faecal incontinence, assessed using the following at baseline and at 6- and 12-months post-operatively:
1. Vaizey/St Mark's score
2. Faecal incontinence quality of life score
Secondary outcome measures
1. Post-operative complications such as peri-prosthetic abscess or anal fistula measured in the immediate post-operative period (1-30 days post-operatively)
2. The correct distribution of the implants measured by endoanal ultrasonography intra-operatively, in the immediate post-operative period and at 6 and 12 months post-op
3. Anorectal physiology with rest and squeeze pressures recorded pre-operatively and at 6 and 12 months post-op
Overall trial start date
01/05/2018
Overall trial end date
01/01/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients receiving Sphinkeeper surgery for faecal incontinence
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Currently there is no set total target enrolment for this study. We aim to collect data on all patients receiving Sphinkeeper surgery. However, a preliminary analysis will be performed once 20 cases are collected.
Participant exclusion criteria
Patients unable to give consent
Recruitment start date
01/11/2018
Recruitment end date
01/11/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Poole Hospital NHS trust
Longfleet Road
Poole
BH15 2JB
United Kingdom
Trial participating centre
St Marks Hospital and Academic Institute
Watford Road
Harrow
HA1 3UJ
United Kingdom
Trial participating centre
Nottingham University Hospitals
Lister Road
Nottingham
NG7 2FT
United Kingdom
Trial participating centre
Wirral University Teaching Hospital NHS Foundation Trust
Clatterbridge Road
Wirral
CH63 4JY
United Kingdom
Trial participating centre
St Helens and Knowsley Teaching Hospitals NHS Trust
Marshalls Cross Road
St Helens
WA9 3DA
United Kingdom
Trial participating centre
Forth Valley Royal Hospital
Stirling Road
Larbert
FK5 4WR
United Kingdom
Trial participating centre
Barts Health NHS Trust
Whitechapel Road
London
E1 1BB
United Kingdom
Trial participating centre
Neville Hall Hospital
Brecon Road
Abergavenny
NP7 7EG
United Kingdom
Sponsor information
Organisation
Poole Hospital
Sponsor details
Longfleet Road
Poole
BH15 2JB
United Kingdom
Sponsor type
Hospital/treatment centre
Website
https://www.poole.nhs.uk/a-z-services/r/research-and-development.aspx
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results will be disseminated through relevant colorectal conferences and meetings. In addition, we aim to publish the study's results in relevant colorectal journals.
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
01/01/2021
Participant level data
Other
Basic results (scientific)
Publication list