Evidence map›Paper›PMID 35593969›Full record

ArticleTechniques in coloproctology2022

An evaluation of the long-term effectiveness of Gatekeeper™ intersphincteric implants for passive faecal incontinence.

S A A Jabbar, J Camilleri-Brennan

Erratum issuedOpen access · hybridAbstract read
In one paragraph

Article in Techniques in coloproctology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
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  3. Observational
  4. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors at 1 institution in 1 country.

S A A JabbarDepartment of Colorectal Surgery, Forth Valley Royal Hospital, Larbert, Stirlingshire, Scotland, UK.
J Camilleri-BrennanDepartment of Colorectal Surgery, Forth Valley Royal Hospital, Larbert, Stirlingshire, Scotland, UK. john.camilleri-brennan@nhs.scot.ORCID 0000-0003-0241-8913
Forth Valley Royal Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImplantation of Gatekeeper™ prostheses presents an option for the treatment of passive faecal incontinence (FI). Whilst preliminary results are encouraging, long-term data regarding its sustained benefit are limited. The aim of this study was to assess and evaluate the long-term clinical function and quality of life of patients with passive faecal incontinence who were treated with Gatekeeper™ prostheses.

methodsThis was a single centre, single surgeon retrospective study of prospectively collected clinical data in patients with FI treated between June 2012 and May 2019. Patients with passive FI with symptoms refractory to conservative treatment and endoanal ultrasonography showing intact or disrupted internal anal sphincter were included. Formal clinical and quality of life assessments were carried out using the St. Mark's Incontinence Score (SMIS) and Faecal Incontinence Quality of Life (FIQoL) questionnaires at baseline, 3 months, 6 months, 12 months and then annually. Endoanal ultrasonography was performed both before and after surgery.

resultsForty patients (14 males, 26 females) with a median age of 62.5 (range 33-80) years were treated with the Gatekeeper™ implant. The majority of patients (87.5%) received six implants. There were no peri or post-operative complications. Prosthesis migration was observed in 12.5% patients. The median follow-up duration was 5 years (interquartile range (IQR) 3.25-6.00 years). A sustained improvement in median SMIS and FIQoL scores from baseline to follow-up was noted. Significant differences were observed between the median baseline SMIS score and last follow-up score of 16.00 (IQR 15.00-16.75) to 7.00 (IQR 5.00-8.00) respectively (p < 0.001), a 56.25% decrease. The overall median FIQoL score showed a significant improvement from 7.95 (IQR 7.13-9.48) to 13.15 (IQR 12.00-13.98) (p < 0.001) a 65.40% increase.

conclusionsGatekeeper™ implantation is a safe approach to treating passive FI and is minimally invasive, reproducible and has minimal complications. Long-term sustained clinical improvement is achievable beyond 5 years. Careful patient selection is paramount, as is consistency of technique and follow-up protocol.

Indexed as

Fecal IncontinenceAdultAgedAged, 80 and overAnal CanalFemaleHumansMaleMiddle AgedProstheses and ImplantsQuality of LifeRetrospective StudiesTreatment OutcomeArtificial anal sphincterBulking agentsEndoanal ultrasonographyFaecal incontinenceGatekeeper™

Identifiers

PMID35593969
PMCPMC9213285
OpenAlexW4280643532

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.