Gatekeeper for Soiling and Gas Incontinence

NCT05222217 | Completed

• 1 other identifier: P21/0001
• Study Type: observational
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gas Incontinence; Soilings, Fecal

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Changes in prostheses location

  baseline and one month after surgery

• Differences in anal pressures

  baseline and three months after surgery

Interventions

Gatekeeper DEVICE

Six polyacrylonitrile prostheses (THD Gatekeeper™ Delivery System, THD SpA, Correggio, Italy) were implanted under 3D-EUS control through a 5mm perianal incision at 1, 3, 5, 7, 9 and 11 o'clock in lithotomy position, and located in the upper-middle intersphincteric space of the anal canal, using a specifically designed system.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Chief of General and Digestive Surgery

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: February 3, 2022
• Study Start: January 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share