Evidence map›Paper›PMID 30940171›Full record

ArticleBMC women's health2019

Evaluation of two vaginal, uterus sparing operations for pelvic organ prolapse: modified Manchester operation (MM) and sacrospinous hysteropexy (SSH), a study protocol for a multicentre randomized non-inferiority trial (the SAM study).

Sascha F M Schulten, Rosa A Enklaar, Kirsten B Kluivers, Sanne A L van Leijsen, Marijke C Jansen-van der Weide, Eddy M M Adang, Jeroen van Bavel, Heleen van Dongen, Maaike B E Gerritse, Iris van Gestel and 12 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC women's health, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.3field-weighted citation impact, top 20% 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

3 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

22 authors at 17 institutions in 1 country.

Sascha F M SchultenDepartment of Obstetrics and Gynaecology, Radboud university medical center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands. sascha.schulten@radboudumc.nl.ORCID 0000-0003-0958-1422
Rosa A EnklaarDepartment of Obstetrics and Gynaecology, Radboud university medical center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.
Kirsten B KluiversDepartment of Obstetrics and Gynaecology, Radboud university medical center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.
Sanne A L van LeijsenDepartment of Obstetrics and Gynaecology, Máxima Medical Centre Veldhoven, De Run, 4600 5500, MB, Veldhoven, The Netherlands.
Marijke C Jansen-van der WeideDepartment of Obstetrics and Gynaecology, Amsterdam University Medical Centre, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Eddy M M AdangDepartment for Health Evidence, Radboud university medical center, Geert Grooteplein 27, 6525 EZ, Nijmegen, The Netherlands.
Jeroen van BavelDepartment of Obstetrics and Gynaecology Amphia Hospital, Molengracht 21, 4818 CK, Breda, The Netherlands.
Heleen van DongenDepartment of Obstetrics and Gynaecology Groene Hart Hospital, Bleulandweg 10, 2803 HH, Gouda, The Netherlands.
Maaike B E GerritseDepartment of Obstetrics and Gynaecology Gelderse Vallei Hospital, Willy Brandtlaan 10, 6716 RP, Ede, The Netherlands.
Iris van GestelDepartment of Obstetrics and Gynaecology, Viecuri Hospital, Tegelseweg 210, 5912 BL, Venlo, The Netherlands.
G G Alec MalmbergDepartment of Obstetrics and Gynaecology, University Medical Centre Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.
Ronald J C MouwDepartment of Obstetrics and Gynaecology, Rijnstate Hospital, Wagnerlaan 55, 6815 AD, Arnhem, The Netherlands.
Deliana A van Rumpt-van de GeestDepartment of Obstetrics and Gynaecology, Reinier de Graaf Hospital, Reinier de Graafweg 5, 8934 AD, Delft, The Netherlands.
Wilbert A SpaansDepartment of Obstetrics and Gynaecology, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands.
Annemarie van der SteenDepartment of Obstetrics and Gynaecology, Ziekenhuisgroep Twente, Zilvermeeuw 1, 7609 PP, Almelo, The Netherlands.
Jelle StekelenburgDepartment of Obstetrics and Gynaecology, Medical Centre Leeuwarden, Henri Dunantweg 2, 8934 AD, Leeuwarden, The Netherlands.
E Stella M TiersmaDepartment of Obstetrics and Gynaecology, Amsterdam University Medical Centre, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Anneke C Verkleij-HagoortDepartment of Obstetrics and Gynaecology, st. Antonius hospital, Koekoekslaan 1, 3435 CM, Nieuwegein, The Netherlands.
Astrid VollebregtDepartment of Obstetrics and Gynaecology, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, The Netherlands.
Chantal B M WingenDepartment of Obstetrics and Gynaecology, Laurentius Hospital, Monseigneur Driessenstraat 6, 6043 CV, Roermond, The Netherlands.
Mirjam WeemhoffDepartment of Obstetrics and Gynecology, Zuyderland Medical Center, Henri Dunantstraat 5, 6419, PC, Heerlen, The Netherlands.
Hugo W F van EijndhovenDepartment of Obstetrics and Gynaecology, Isala Zwolle, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands.
Radboud University Nijmegen · NLUniversity of Amsterdam · NLAmphia Ziekenhuis · NLGroene Hart Ziekenhuis · NLIsala · NLLaurentius Ziekenhuis · NLMaastricht University Medical Centre · NLMedisch Centrum Leeuwarden · NLMedisch Spectrum Twente · NLReinier de Graaf Hospital · NLRijnstate Hospital · NLSpaarne Ziekenhuis · NLSt. Antonius Ziekenhuis · NLUniversity Medical Center Groningen · NLVieCuri Medisch Centrum · NLZiekenhuis Gelderse Vallei · NLZuyderland Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPelvic organ prolapse (POP) affects up to 40% of parous women which adversely affects the quality of life. During a life time, 20% of all women will undergo an operation. In general the guidelines advise a vaginal operation in case of uterine descent: hysterectomy with uterosacral ligament plication (VH), sacrospinous hysteropexy (SSH) or a modified Manchester operation (MM). In the last decade, renewed interest in uterus sparing techniques has been observed. Previous studies have shown non-inferiority between SSH and VH. Whether or not SSH and MM are comparable concerning anatomical and functional outcome is still unknown. The practical application of both operations is at least in The Netherlands a known cause of practice pattern variation (PPV). To reveal any difference between both techniques the SAM-study was designed.

methodsThe SAM-study is a randomized controlled multicentre non-inferiority study which compares SSH and MM. Women with symptomatic POP in any stage, uterine descent and POP-Quantification (POP-Q) point D at ≤ minus 1 cm are eligible. The primary outcome is the composite outcome at two years of absence of prolapse beyond the hymen in any compartment, the absence of bulge symptoms and absence of reoperation for pelvic organ prolapse. Secondary outcomes are hospital parameters, surgery related morbidity/complications, pain perception, further treatments for prolapse or urinary incontinence, POP-Q anatomy in all compartments, quality-of-life, sexual function, and cost-effectiveness. Follow-up takes place at 6 weeks, 12 and 24 months. Additionally at 12 weeks, 6 and 9 months cost-effectiveness will be assessed. Validated questionnaires will be used and gynaecological examination will be performed. Analysis will be performed following the intention-to-treat and per protocol principle. With a non-inferiority margin of 9% and an expected loss to follow-up of 10%, 424 women will be needed to prove non-inferiority with a confidence interval of 95%. DISCUSSION: This study will evaluate the effectiveness and costs of SSH versus MM in women with primary POP. The evidence will show whether the existing PPV is detrimental and a de-implementation process regarding one of the operations is needed.

trial registrationDutch Trial Register (NTR 6978, http://www.trialregister.nl ). Date of registration: 29 January 2018. Prospectively registered.

Indexed as

Pelvic Organ ProlapseRound Ligament of UterusUterusVaginaAdultEquivalence Trials as TopicFemaleGynecologic Surgical ProceduresHumansMiddle AgedMulticenter Studies as TopicNetherlandsQuality of LifeRandomized Controlled Trials as TopicSeverity of Illness IndexSurgical MeshCost-utilityModified Manchester operationPelvic organ prolapsePOP-QRandomized clinical trialReconstructive surgerySacrospinous hysteropexyUterine descent

Identifiers

PMID30940171
PMCPMC6444578
OpenAlexW2940758776

What OpenQuestion holds

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LicenceCC BY
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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.