Condition category
Digestive System
Date applied
26/10/2018
Date assigned
15/11/2018
Last edited
15/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes