Anal Sphinkeeper in patients with faecal incontinence: a multicentre prospective evaluation in the UK

Not Applicable

• Conditions: Faecal incontinence; Digestive System

• Registration Number: ISRCTN61603070
• Lead Sponsor: Poole Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-15
• Last Update Posted: 11 March 2024
• Study Completion: 2025-12-23

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

All patients receiving Sphinkeeper surgery for faecal incontinence

Exclusion Criteria

Patients unable to give consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Faecal incontinence, assessed using the following at baseline and at 6- and 12-months post-operatively:<br>1. Vaizey/St Mark's score<br>2. Faecal incontinence quality of life score

Secondary Outcome Measures

Name	Time	Method
1. Post-operative complications such as peri-prosthetic abscess or anal fistula measured in the immediate post-operative period (1-30 days post-operatively)<br>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<br>3. Anorectal physiology with rest and squeeze pressures recorded pre-operatively and at 6 and 12 months post-op