Evidence map›Paper›PMID 26658726›Full record

ArticleTechniques in coloproctology2016

Implantation of SphinKeeper(TM): a new artificial anal sphincter.

C Ratto, L Donisi, F Litta, P Campennì, A Parello

Registry-linked trialOpen access · hybridAbstract readEvaluation Study
In one paragraph

Article in Techniques in coloproctology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03080753 (Treatment of Anal Incontinence Using Intersphincteric Implants), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 12% 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.

NCT03080753 naterminatednot on this mapstarted 2017, after this paper: background citation

Treatment of Anal Incontinence Using Intersphincteric Implants (SphinKeeper)

TypeinterventionalSponsorRegion SkaneRan2017 to 2019Enrolled10ConditionsAnal Incontinence, Fecal IncontinenceArmsSphinkeeper
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Observational
  6. Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Review
  12. Observational
  13. Sphinkeeper™ for faecal incontinence: a preliminary report.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2020
    Article
  14. Article
  15. Outcomes of GatekeeperTechniques in coloproctology · 2017
    Observational
  16. Fecal incontinence - Challenges and solutions.World journal of gastroenterology · 2017
    Review
  17. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

C RattoProctology Unit, Department of Surgical Sciences, Catholic University, Largo A. Gemelli, 8, 00168, Rome, Italy. carloratto@tiscali.it.
L DonisiProctology Unit, Department of Surgical Sciences, Catholic University, Largo A. Gemelli, 8, 00168, Rome, Italy.
F LittaProctology Unit, Department of Surgical Sciences, Catholic University, Largo A. Gemelli, 8, 00168, Rome, Italy.
P CampennìProctology Unit, Department of Surgical Sciences, Catholic University, Largo A. Gemelli, 8, 00168, Rome, Italy.
A ParelloProctology Unit, Department of Surgical Sciences, Catholic University, Largo A. Gemelli, 8, 00168, Rome, Italy.
Università Cattolica del Sacro Cuore · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionA new artificial anal sphincter, SphinKeeper(TM), was devised with the aim to treat fecal incontinence (FI) by implanting specifically designed self-expandable prostheses into the intersphincteric space. Preliminary data concerning the procedure feasibility and prosthesis localization at 3 months are presented.

methodsSphinKeeper(TM) prostheses in the native state are dehydrated, thin, solid cylinder (length 29 mm, diameter 3 mm), changing their state (shorter--length 23 mm, thicker--diameter 7 mm--and softer, with shape memory) within 48 h of contact with fluids. In this study, 10 prostheses were implanted in each patient with FI under local anesthesia and under endoanal ultrasound (EAUS) guidance, into the upper-middle intersphincteric space of the anal canal by a specifically designed delivery system. EAUS was used postoperatively to assess prostheses dislocation.

resultsTen patients (5 females; median age 58 years, range 20-75) were enrolled and treated with SphinKeeper(TM) implantation. Median duration of procedure (performed by endoanal ultrasound guidance) was 40 min (range 30-45). Neither intraoperative nor postoperative complications were reported after a 3-month follow-up. In one patient, a partial dislocation of a single prosthesis was documented by EAUS, causing anal discomfort which resolved after 1 week.

conclusionSphinKeeper(TM) can be safely implanted in patients with FI of different etiology. Implantation was well tolerated with no dislodgment of implants at 3-month follow-up.

Indexed as

Anal CanalArtificial OrgansProsthesis DesignAdultAgedEndosonographyFecal IncontinenceFemaleFollow-Up StudiesHumansMaleMiddle AgedOperative TimePostoperative ComplicationsProsthesis ImplantationTransanal Endoscopic SurgeryArtificial anal sphincterBulking agentsDynamic graciloplastyFecal incontinenceGatekeeperSacral nerve stimulationSphincter lesionSphincteroplasty

Identifiers

PMID26658726
PMCPMC4751162
OpenAlexW2418456871

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.