Evidence map›Paper›PMID 36645441›Full record

Observational studyInternational urogynecology journal2023

A novel anchoring system for pelvic organ prolapse repair: an observational study.

Heather van Raalte, Nina Bhatia, Jeffrey Mangel, Hugo Ryckebusch, Jan-Paul Roovers

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in International urogynecology journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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, 4 citations in OpenAlex.

  1. Article
  2. Observational
  3. Article
  4. Article
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 4 institutions in 2 countries.

Heather van RaaltePenn Medicine Princeton Medical Center, Princeton, NJ, USA.
Nina BhatiaHackensack Meridian Health Medical Group, Old Bridge, NJ, USA.
Jeffrey MangelMetroHealth Medical Center, Cleveland, OH, USA.
Hugo RyckebuschColoplast Manufacturing France, Le Plessis-Robinson cedex, France.
Jan-Paul RooversAmsterdam UMC, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, Netherlands. j.p.roovers@amsterdamumc.nl.ORCID 0000-0002-3069-6382
Bergman Clinics · NLHackensack Meridian Health · USMetroHealth · USUniversity Medical Center of Princeton · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introduction and hypothesisSacrospinous ligament (SSL) fixation is an effective and widely used vaginal procedure for correcting apical prolapse. The Saffron Fixation System (Coloplast Corp., Minneapolis, MN, USA) is a new anchoring device aimed at facilitating a durable, easy, and short procedure for SSL fixation with the goal of minimizing operative complications. The objective was to demonstrate the efficacy and safety of anchor deployment and suture fixation for pelvic organ prolapse repair using the Saffron Fixation System.

methodsAn observational human cadaver study was conducted to measure the distance between anchor location and anatomical landmarks in the pelvis, and the holding force of the fixated anchors. Anchors were placed in four human cadavers by different implanters. The pull-out force of these anchors was measured to assess efficacy (three cadavers by three implanters) and the distance between anchors and primal vessels and nerves was measured to assess safety (one cadaver by one implanter).

resultsNineteen out of 20 anchors (95%) were correctly placed as judged by independent assessment performed by non-implanting surgeons. Distance between anchors and surrounding nerves and vessels exceeded 10 mm. Mean (SD) pull out-force was 17.9 (5.6) N.

conclusionThe innovative anchoring device that was developed appeared to enable precise and solid anchor placement in the SSL. Future clinical studies are needed to explore if the theoretical advantages of this device translate to improved clinical outcomes in comparison with available suturing and anchoring devices.

Indexed as

Pelvic Organ ProlapseCadaverFemaleGynecologic Surgical ProceduresHumansLigamentsLigaments, ArticularPelvisTreatment OutcomeVaginaAnchoring deviceNative tissue surgeryPelvic organ prolapseSacrospinous ligament fixationSafety

Identifiers

PMID36645441
PMCPMC10287791
OpenAlexW4316465020

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.