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OpenTrials
Completed

NCT Number: NCT05222217

Gatekeeper for Soiling and Gas Incontinence

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

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Key information

Conditions

Gas Incontinence Digestive System Diseases Fecal Incontinence Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Soilings, Fecal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in the number of gas incontinence and soiling episodes

    Time frame: 6, 12 and 24 months after surgery

    Each patient completes a three-week continence diary specifically recording gas incontinence and soiling episodes at baseline and before every follow-up visit.

  2. Changes in incontinence symptoms

    Time frame: 6, 12 and 24 months after surgery

    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"

  3. Patient's Subjective Perception

    Time frame: 6, 12 and 24 months after surgery

    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"

Secondary outcomes

  1. Changes in prostheses location

    Time frame: baseline and one month after surgery

    Prostheses migration was defined as displacement of the prosthesis to the suprasphincteric space detected during the follow-up, detected with 3D-Endoanal Ultrasound.

  2. Differences in anal pressures

    Time frame: baseline and three months after surgery

    Measurement of differences in anal testing pressures using a four-channel manometer

Sponsors and collaborators

Lead sponsor

Hospital Mutua de Terrassa

Other

Registry information

Official study title

Gatekeeper™ Prostheses Implants for Patients With Gas Incontinence and Soiling

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 3, 2022
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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