Gas IncontinenceNCT05222217
Gatekeeper for Soiling and Gas Incontinence
An observational study of Gas Incontinence and Soilings, Fecal, run by Hospital Mutua de Terrassa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gas Incontinence, Soilings, Fecal
- What is being tested?
- Gatekeeper
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- patients older than 18 years old
- with at least 6 months of GI and/or soiling
- non-responding to conservative treatment and biofeedback.
Who cannot join
- complete solid and liquid FI
- common Bristol score > 4
- malignant diseases
- chronic diarrhoea
- inflammatory bowel disease
- acute anorectal disease
Show all 14Show fewer
- 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.
About this study
Official title: 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
- Conditions
- Gas Incontinence, Soilings, Fecal
- Being tested
- Gatekeeper
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GatekeeperDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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"
Measured: 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"
Measured: 6, 12 and 24 months after surgery
Secondary outcomes (2)
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.
Measured: baseline and one month after surgery
Differences in anal pressures
Measurement of differences in anal testing pressures using a four-channel manometer
Measured: baseline and three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study startJan 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gas IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arantxa Muñoz-Duyos, Hospital Mutua de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222217
- Sponsor's protocol ID
- P21/0001
- Status last verified
- Feb 2022
- First submitted
- 24 Dec 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gatekeeper™ Prostheses Implants for Patients With Gas Incontinence and Soiling
- ClinicalTrials.gov ID
- NCT05222217
- Acronym / sponsor ID
- P21/0001
- Conditions
- Gas Incontinence, Soilings, Fecal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- patients older than 18 years old
- with at least 6 months of GI and/or soiling
- non-responding to conservative treatment and biofeedback.
Key exclusion criteria (14 listed)
- complete solid and liquid FI
- common Bristol score > 4
- malignant diseases
- chronic diarrhoea
- inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GatekeeperSix 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. | Device | – |
Primary outcome
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.
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"
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"
2 secondary outcomes
Changes in prostheses location
Time frame: baseline and one month after surgery
Differences in anal pressures
Time frame: baseline and three months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gas Incontinence and Soilings, Fecal, run by Hospital Mutua de Terrassa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of gas incontinence and soiling episodes (time frame: 6, 12 and 24 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.