Evidence map›Paper›PMID 32166489›Full record

ArticleEuropean radiology2020

Development and clinical evaluation of a 3-step modified manipulation protocol for MRI-guided high-intensity focused ultrasound of uterine fibroids.

Inez M Verpalen, Miranda van 't Veer-Ten Kate, Erwin de Boer, Rolf D van den Hoed, Joke M Schutte, Jeroen R Dijkstra, Arie Franx, Lambertus W Bartels, Chrit T W Moonen, Martijn F Boomsma

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Article in European radiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.2field-weighted citation impact, top 17% 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

6 citing papers in PubMed, 17 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

10 authors at 3 institutions in 1 country.

Inez M VerpalenDepartment of Radiology, Isala Hospital, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands. i.m.verpalen@isala.nl.
Miranda van 't Veer-Ten KateDepartment of Radiology, Isala Hospital, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands.
Erwin de BoerDepartment of Radiology, Isala Hospital, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands.
Rolf D van den HoedDepartment of Radiology, Isala Hospital, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands.
Joke M SchutteDepartment of Gynecology, Isala, Zwolle, The Netherlands.
Jeroen R DijkstraDepartment of Gynecology, Isala, Zwolle, The Netherlands.
Arie FranxDepartment of Obstetrics and Gynecology, Erasmus Medical Center, Rotterdam, The Netherlands.
Lambertus W BartelsImage Sciences Institute, Imaging Division, University Medical Center Utrecht, Utrecht, The Netherlands.
Chrit T W MoonenImage Sciences Institute, Imaging Division, University Medical Center Utrecht, Utrecht, The Netherlands.
Martijn F BoomsmaDepartment of Radiology, Isala Hospital, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands.
Isala · NLUniversity Medical Center Utrecht · NLErasmus MC · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe clinical applicability of magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) treatment of uterine fibroids is often limited due to inaccessible fibroids or bowel interference. The aim of this study was to implement a newly developed 3-step modified manipulation protocol and to evaluate its influence on the number of eligible women and treatment failure rate.

methodsFrom June 2016 to June 2018, 165 women underwent a screening MRI examination, 67 women of whom were consecutively treated with MR-HIFU at our institution. Group 1 (n = 20) was treated with the BRB manipulation protocol which consisted of sequential applications of urinary bladder filling, rectal filling, and urinary bladder emptying. Group 2 (n = 47) was treated using the 3-step modified manipulation protocol which included (1) the BRB maneuver with adjusted rectal filling by adding psyllium fibers to the solution; (2) Trendelenburg position combined with bowel massage; (3) the manual uterine manipulation (MUM) method for uterine repositioning. A comparison was made between the two manipulation protocols to evaluate differences in safety, the eligibility percentage, and treatment failure rate due to unsuccessful manipulation.

resultsAfter implementing the 3-step modified manipulation protocol, our ineligibility rate due to bowel interference or inaccessible fibroids decreased from 18% (16/88) to 0% (0/77). Our treatment failure rate due to unsuccessful manipulation decreased from 20% (4/20) to 2% (1/47). There were no thermal complications to the bowel or uterus.

conclusionsImplementation of the 3-step modified manipulation protocol during MR-HIFU therapy of uterine fibroids improved the eligibility percentage and reduced the treatment failure rate.

trial registrationRegistry number NL56182.075.16 KEY POINTS: • A newly developed 3-step modified manipulation protocol was successfully implemented without the occurrence of thermal complication to the bowel or uterus. • The 3-step modified manipulation protocol increased our eligibility percentage for MR-HIFU treatment of uterine fibroids. • The 3-step modified manipulation protocol reduced our treatment failure rate for MR-HIFU treatment of uterine fibroids.

Indexed as

AdultClinical ProtocolsFemaleHigh-Intensity Focused Ultrasound AblationHumansLeiomyomaMagnetic Resonance Imaging, InterventionalTreatment OutcomeUterine NeoplasmsUterusHigh-intensity focused ultrasound ablationMR-guided interventional proceduresPatient selectionUterine fibroids

Identifiers

PMID32166489
OpenAlexW3012217624

What OpenQuestion holds

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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.