Evidence map›Paper›PMID 31506252›Full record

Observational studyBMJ (Clinical research ed.)2019

Sacrospinous hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension in women with uterine prolapse stage 2 or higher: observational follow-up of a multicentre randomised trial.

Sascha F M Schulten, Renée J Detollenaere, Jelle Stekelenburg, Joanna IntHout, Kirsten B Kluivers, Hugo W F van Eijndhoven

Open access · hybridAbstract readComparative StudyObservational Study
In one paragraph

Observational study in BMJ (Clinical research ed.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 2 pooled it
10.9field-weighted citation impact, top 1% 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

44 citing papers in PubMed, 2 syntheses or guidelines pooled it, 118 citations in OpenAlex.

  1. Pooled it
  2. Surgery for women with apical vaginal prolapse.The Cochrane database of systematic reviews · 2023
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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.

Sascha F M SchultenDepartment of Obstetrics and Gynaecology, Isala Clinics, PO Box 10400, 8000 GK Zwolle, Netherlands.
Renée J DetollenaereDepartment of Obstetrics and Gynaecology, Isala Clinics, PO Box 10400, 8000 GK Zwolle, Netherlands r.j.detollenaere@isala.nl.ORCID http://orcid.org/0000-0001-9707-5647
Jelle StekelenburgDepartment of Obstetrics and Gynaecology, Medical Centre Leeuwarden, Leeuwarden, Netherlands.
Joanna IntHoutRadboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, Netherlands.
Kirsten B KluiversDepartment of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, Netherlands.
Hugo W F van EijndhovenDepartment of Obstetrics and Gynaecology, Isala Clinics, PO Box 10400, 8000 GK Zwolle, Netherlands.
Radboud University Nijmegen · NLIsala · NLUniversity Medical Center Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the effectiveness and success of uterus preserving sacrospinous hysteropexy as an alternative to vaginal hysterectomy with uterosacral ligament suspension in the surgical treatment of uterine prolapse five years after surgery.

designObservational follow-up of SAVE U (sacrospinous fixation versus vaginal hysterectomy in treatment of uterine prolapse ≥2) randomised controlled trial.

settingFour non-university teaching hospitals, the Netherlands.

participants204 of 208 healthy women in the initial trial (2009-12) with uterine prolapse stage 2 or higher requiring surgery and no history of pelvic floor surgery who had been randomised to sacrospinous hysteropexy or vaginal hysterectomy with uterosacral ligament suspension. The women were followed annually for five years after surgery. This extended trial reports the results at five years.

main outcome measuresPrespecified primary outcome evaluated at five year follow-up was recurrent prolapse of the uterus or vaginal vault (apical compartment) stage 2 or higher evaluated by pelvic organ prolapse quantification system in combination with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse. Secondary outcomes were overall anatomical failure (recurrent prolapse stage 2 or higher in apical, anterior, or posterior compartment), composite outcome of success (defined as no prolapse beyond the hymen, no bothersome bulge symptoms, and no repeat surgery or pessary use for recurrent prolapse), functional outcome, quality of life, repeat surgery, and sexual functioning.

resultsAt five years, surgical failure of the apical compartment with bothersome bulge symptoms or repeat surgery occurred in one woman (1%) after sacrospinous hysteropexy compared with eight women (7.8%) after vaginal hysterectomy with uterosacral ligament suspension (difference-6.7%, 95% confidence interval -12.8% to-0.7%). A statistically significant difference was found in composite outcome of success between sacrospinous hysteropexy and vaginal hysterectomy (89/102 (87%)

conclusionsAt five year follow-up significantly less anatomical recurrences of the apical compartment with bothersome bulge symptoms or repeat surgery were found after sacrospinous hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension. After hysteropexy a higher proportion of women had a composite outcome of success. Time-to-event analysis showed no differences in outcomes between the procedures.

trial registrationtrialregister.nl NTR1866.

Indexed as

Hysterectomy, VaginalLigamentsQuality of LifeUterine ProlapseAdultAgedAged, 80 and overFemaleFollow-Up StudiesHumansMiddle AgedMulticenter Studies as TopicNetherlandsRandomized Controlled Trials as TopicRecurrenceReoperation

Identifiers

PMID31506252
PMCPMC6734519
OpenAlexW2972634607

What OpenQuestion holds

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LicenceCC BY-NC
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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.