Evidence map›Paper›PMID 35683436›Full record

ArticleJournal of clinical medicine2022

Safety and Effectiveness of a New Electrical Detachable Microcoil for Embolization of Hemorrhoidal Disease, November 2020-December 2021: Results of a Prospective Study.

Miguel Angel De Gregorio, Román Bernal, Juan Jose Ciampi-Dopazo, José Urbano, Alfonso Millera, José Andres Guirola

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.3field-weighted citation impact, top 21% 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

7 citing papers in PubMed, 7 citations in OpenAlex.

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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

6 authors at 3 institutions in 1 country.

Miguel Angel De GregorioInterventional Radiology, Hospital Clínica Quirón Salud, 50006 Zaragoza, Spain.ORCID 0000-0002-5618-7519
Román BernalInterventional Radiology, Hospital Clínica Quirón Salud, 50006 Zaragoza, Spain.ORCID 0000-0002-2471-4847
Juan Jose Ciampi-DopazoInterventional Radiology, Hospital Virgen de las Nieves, 18001 Granada, Spain.
José UrbanoGrupo de Investigación en Técnicas Minimamente Invasivas (GITMI), University of Zaragoza, 500013 Zaragoza, Spain.ORCID 0000-0003-4138-7697
Alfonso MilleraDepartment of Surgery, Hospital Clínico Universitario Lozano Blesa, 50009 Zaragoza, Spain.
José Andres GuirolaGrupo de Investigación en Técnicas Minimamente Invasivas (GITMI), University of Zaragoza, 500013 Zaragoza, Spain.ORCID 0000-0002-0113-5121
Universidad de Zaragoza · ESHospital Clínico Universitario Lozano Blesa · ESHospital Universitario Virgen de las Nieves · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe purpose of this study was to prospectively evaluate the efficacy and safety of a new, bare platinum, detachable microcoil as a metallic embolization agent in the treatment of hemorrhoidal disease. MATERIAL AND

methodsThis prospective single-center study evaluated a new, bare platinum, electrical, detachable microcoil (Prestige plus coil (Balt Montmorency France)) for use in vascular embolization in patients with hemorrhoidal disease. Between January 2020 and January 2021, 24 embolization procedures were performed in 21 patients (12 males, 9 females; mean age 44.3 ± 7.3). The inclusion criteria were: (a) participants with grade I, II and III hemorrhoidal disease on the Goligher classification; (b) patients older than 18 years of age with a score of greater than 4 on the French bleeding score (FBS) scale; (c) patients with scores greater than 2 on the scale of discomfort proposed by Tradi and Farfallah. (d) patients who underwent treatment that included the use of the new novel coil (Prestige plus coil (Balt)) as an embolic material. The exclusion criteria were participants who failed to provide informed consent and participants diagnosed with rectal bleeding due to other causes (cancer, fissures or others). Participants with severe renal insufficiency, non-correctable coagulation abnormalities and adverse reactions to the contrast medium not correctable with medication were also excluded. The symptoms, technical aspects, the transarterial approach, clinical and technical success complications and short-term outcomes were assessed.

resultsTechnical success was obtained in 100% of the cases. Seventeen (80.9%) patients experienced improvements in their hemorrhoidal disease. The VAS and QL scores improved by 4 and 1.5 points (81.2% and 87.5%), respectively, after embolization (pV: 0001). Three (14.2%) patients underwent a second embolization due to rebleeding. One patient (4.7%) underwent surgery. No major complications were observed. Three patients had minor complications. The assessment of subjective post-treatment symptoms and QL surveys showed significant differences from the baseline survey. Likewise, the measurement of the degree of satisfaction using a telephone survey at 12 months revealed a high degree of patient satisfaction over 10 points (mean 8.3 ± 1.1).

conclusionsThe present study demonstrates that the use of the new, platinum, detachable, electrical microcoil is safe and well-tolerated in the treatment of hemorrhoidal disease. KEY POINTS: Catheter-directed hemorrhoidal dearterialization (CDHD) is the procedure of embolization with embolic agents for the treatment of internal hemorrhoids. CDHD is a simple and safe procedure that is accepted by patients and preserves the anal sphincter; it presents few complications when metal devices or microspheres are used as embolic agents. As the recommended embolization agent in treatments, the Prestige electrical, detachable coil is a safe, easy-to-use and effective arterial embolic device.

Indexed as

catheter-directed hemorrhoidal dearterialization (CDHD)internal hemorrhoidstreatment

Identifiers

PMID35683436
PMCPMC9181639
OpenAlexW4281787147

What OpenQuestion holds

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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.