An observational study in Gas Incontinence and Soilings, Fecal, sponsored by Hospital Mutua de Terrassa. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-03.
Sponsored by Hospital Mutua de Terrassa · Observational
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
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's enrollment of 13 is below the median of 100 across 79 observational studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Hospital Mutua de Terrassa is the lead sponsor of 33 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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.
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.
Time frame: 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"
Time frame: 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"
Time frame: 6, 12 and 24 months after surgery
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.
Time frame: baseline and one month after surgery
Differences in anal pressures
Measurement of differences in anal testing pressures using a four-channel manometer
Time frame: baseline and three months after surgery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Hospital Mutua de Terrassa