Evidence map›Paper›PMID 39358750›Full record

ArticleTrials2024

The influence of simultaneous posterior colporrhaphy and perineoplasty on the efficiency and safety of mesh-augmented sacrospinal fixation (apical sling) in advanced POP repair.

Rustam A Shakhaliev, Andrey S Shulgin, Nikita D Kubin, Anton S Kondratiev, Denis A Suchkov, Sofia V Neklasova, Dmitry D Shkarupa

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05422209 (The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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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.

NCT05422209 naunknown statusnot on this map

The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair. Randomized Controlled Study.

TypeinterventionalSponsorSaint Petersburg State University, RussiaRan2022 to 2025Enrolled310ConditionsPelvic Organ ProlapseArmsMesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty., Mesh-augmented sacrospinal fixation with posterior colporrhaphy.
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

Rustam A ShakhalievSaint-Petersburg State University Hospital (SPSU Hospital), 154 Fontanka Embankment, Saint-Petersburg, 190103, Russian Federation. rustam.shahaliev@gmail.com.ORCID http://orcid.org/0000-0003-2450-7044
Andrey S ShulginSaint-Petersburg State University Hospital (SPSU Hospital), 154 Fontanka Embankment, Saint-Petersburg, 190103, Russian Federation.ORCID http://orcid.org/0000-0002-8655-7234
Nikita D KubinSaint-Petersburg State University Hospital (SPSU Hospital), 154 Fontanka Embankment, Saint-Petersburg, 190103, Russian Federation.ORCID http://orcid.org/0000-0001-5189-4639
Anton S KondratievSaint-Petersburg State University Hospital (SPSU Hospital), 154 Fontanka Embankment, Saint-Petersburg, 190103, Russian Federation.
Denis A SuchkovSaint-Petersburg State University Hospital (SPSU Hospital), 154 Fontanka Embankment, Saint-Petersburg, 190103, Russian Federation.ORCID http://orcid.org/0000-0002-0649-9434
Sofia V NeklasovaSaint-Petersburg State University Hospital (SPSU Hospital), 154 Fontanka Embankment, Saint-Petersburg, 190103, Russian Federation.ORCID http://orcid.org/0009-0000-7614-1270
Dmitry D ShkarupaSaint-Petersburg State University Hospital (SPSU Hospital), 154 Fontanka Embankment, Saint-Petersburg, 190103, Russian Federation.ORCID http://orcid.org/0000-0003-0489-3451

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPelvic organ prolapse (POP) is one of the most common pathologies of the pelvic floor, and it can be found among 40-60% of women who have given birth. Correction of the defect of the DeLancey level II without reconstruction of the apical defect is doomed to failure. Also, in the structure of pelvic floor defects, there is often an incompetency of the perineal body, as a consequence of traumatic delivery. Perineoplasty is considered to be the main method of correction for perineal body incompetency. However, it is worth mentioning that there are no randomized trials, which estimate the influence of simultaneous correction of the perineal body on the effectiveness of transvaginal apical fixation.

methodsIt is planned to include 310 patients in this trial. Patients who met the inclusion/exclusion criteria will be randomized into 2 groups: 1st group-patients who will undergo mesh-augmented sacrospinal fixation with anterior and posterior colporrhaphy without perineoplasty, 2nd group-patients who will undergo mesh-augmented sacrospinal fixation with anterior and posterior colporrhaphy and perineoplasty. Patients will be called to an appointment 6, 12, and 24 months after discharge. DISCUSSION: The aim of this trial is to evaluate the efficiency and safety of simultaneous perineoplasty on the clinical and anatomical efficacy of mesh-augmented sacrospinal fixation in advanced pelvic organ prolapse repair. Based on previous studies, it was difficult to estimate and comprehend whether colpoperinoplasty actually reduces the risk of prolapse recurrence.

trial registrationNCT05422209. Registered on 18 May 2022.

Indexed as

Pelvic Organ ProlapsePerineumSurgical MeshAdultAgedFemaleGynecologic Surgical ProceduresHumansMiddle AgedPelvic FloorRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeVaginaColporrhaphyPelvic organ prolapsePerineoplastySacrospinous fixationVaginal meshVaginal repair

Identifiers

PMID39358750
PMCPMC11446006

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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.