Gatekeeper for Soiling and Gas Incontinence

Gatekeeper™ Prostheses Implants for Patients With Gas Incontinence and Soiling

Faecal incontinence has a broad spectrum of symptoms. Some patients only suffer commonly considered mild symptoms: gas incontinence and soiling, but patients' quality of life is significantly impaired. Although several treatments for faecal incontinence are available, this subgroup of patients are difficult to treat, and no therapeutic alternative has been clearly defined.

The aim of this study is to evaluate Gatekeeper™ treatment for this subgroup of patients with faecal incontinence, not studied before.

Consecutive case series single-centre study. Patients with mainly soiling and/or gas incontinence were treated with polyacrylonitrile prostheses

Study Overview

• Status: Completed
• Conditions: Gas Incontinence; Soilings, Fecal
• Intervention / Treatment: Device: Gatekeeper

• Study Type: Observational
• Enrollment (Actual): 13

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients' selection was based on clinical history, physical examination, preoperative 3D-endoanal ultrasound (EUS) and a continence diary recorded for 21 days. Patients with previous history of chronic diarrhoea were evaluated by the gastroenterology team and if needed, fibre supplementation or other medical treatment was used to obtain a Bristol score of 3-4 before entering the study

Description

Inclusion Criteria:

• patients older than 18 years old
• with at least 6 months of GI and/or soiling
• non-responding to conservative treatment and biofeedback.

Exclusion Criteria:

• complete solid and liquid FI
• common Bristol score > 4
• malignant diseases
• chronic diarrhoea
• inflammatory bowel disease
• acute anorectal disease
• rectal prolapse
• neurological disease,
• obstructive defecation syndrome
• low anterior resection syndrome,
• previous pelvic radiation,
• any anaesthetic contraindication
• St. Mark's score > 12
• external anal sphincter lesion > 30º.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the number of gas incontinence and soiling episodes	Each patient completes a three-week continence diary specifically recording gas incontinence and soiling episodes at baseline and before every follow-up visit.	6, 12 and 24 months after surgery
Changes in incontinence symptoms	Evaluation of incontinence symptoms with the St. Mark's Incontinence Score. Score from 0 to 24, where 0 means "complete continence" and 24 means "severe fecal incontinence"	6, 12 and 24 months after surgery
Patient's Subjective Perception	Changes in patient subjective evaluation using a Visual Analogue Scale (VAS). Score from 0 to 10, where 0 means "no problem" and 10 means "severe problem and alteration of my quality of life"	6, 12 and 24 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in prostheses location	Prostheses migration was defined as displacement of the prosthesis to the suprasphincteric space detected during the follow-up, detected with 3D-Endoanal Ultrasound.	baseline and one month after surgery
Differences in anal pressures	Measurement of differences in anal testing pressures using a four-channel manometer	baseline and three months after surgery

Collaborators and Investigators

• Sponsor: Hospital Mutua de Terrassa

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 24, 2021
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: P21/0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No