Anal Sphinkeeper in patients with faecal incontinence: a multicentre prospective evaluation in the UK
| ISRCTN | ISRCTN61603070 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61603070 |
| Secondary identifying numbers | SK01 |
- Submission date
- 26/10/2018
- Registration date
- 15/11/2018
- Last edited
- 01/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
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 December 2025
Who is funding the study?
Self-funded
Who is the main contact?
Andrew Clarke
andrew.clarke@uhd.nhs.uk
Contact information
Public
Poole Hospital
Longfleet Road
Poole
BH15 2JB
Poole
BH15 2JB
United Kingdom
| Phone | +44 (0)1202665511 |
|---|---|
| andrew.clarke@uhd.nhs.uk |
Study information
| Study design | Prospective observational case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study hypothesis | Anal Sphinkeeper is a safe and effective method of treating faecal incontinence |
| Ethics approval(s) | 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. |
| 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 | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | SphinKeeper® |
| 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 study start date | 01/05/2018 |
| Overall study end date | 23/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | 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 inclusion criteria | All patients receiving Sphinkeeper surgery for faecal incontinence |
| Participant exclusion criteria | Patients unable to give consent |
| Recruitment start date | 01/11/2018 |
| Recruitment end date | 01/11/2020 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Poole
BH15 2JB
United Kingdom
Harrow
HA1 3UJ
United Kingdom
Nottingham
NG7 2FT
United Kingdom
Wirral
CH63 4JY
United Kingdom
St Helens
WA9 3DA
United Kingdom
Larbert
FK5 4WR
United Kingdom
London
E1 1BB
United Kingdom
Abergavenny
NP7 7EG
United Kingdom
Sponsor information
Hospital/treatment centre
Longfleet Road
Poole
BH15 2JB
England
United Kingdom
| Website | https://www.poole.nhs.uk/a-z-services/r/research-and-development.aspx |
|---|---|
"ROR" |
https://ror.org/00ph04139 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| 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 plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Editorial Notes
01/03/2024: A contact email was changed.
17/01/2023: The overall trial end date has been changed from 01/01/2020 to 23/12/2025 and the plain English summary updated accordingly.
