HOPPSA update: changes in the study protocol of Hysterectomy and OPPortunistic SAlpingectomy, a registry-based randomized controlled trial

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Idahl, Annika,1965-Umeå universitet,Obstetrik och gynekologi (author)

HOPPSA update: changes in the study protocol of Hysterectomy and OPPortunistic SAlpingectomy, a registry-based randomized controlled trial

Article/chapterEnglish2023

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2023-03-24
Springer Science and Business Media LLC,2023

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LIBRIS-ID:oai:gup.ub.gu.se/326157
https://gup.ub.gu.se/publication/326157URI
https://doi.org/10.1186/s13063-023-07244-wDOI
https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-206351URI

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Language:English

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SwePubSwePub

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Subject category:ref swepub-contenttype
Subject category:art swepub-publicationtype

Notes

Background The HOPPSA trial is a multi-center national registry-based randomized controlled trial to test the safety and effectiveness of performing opportunistic salpingectomy at hysterectomy to reduce the risk of epithelial ovarian cancer (EOC). The study protocol was first published in January 2019 and is available at . Here, we report amendments made to the study protocol since commencement of the trial.Changes in methods and analysis The primary outcomes analyses have been changed. (1) Complications will be analyzed using binomial generalized estimating equation (GEE) with log link function, while the unadjusted analyses according to Miettinen and Nurminen will be performed as a sensitivity analysis. (2) Absolute change in Menopause Rating Scale (MRS) will primarily be analyzed using a mixed effects model, adjusted for baseline MRS and center as a random effect. (3) Time to EOC will be analyzed using the mixed effects Cox regression model with center as random effect, while the unadjusted log-rank test will be performed as a sensitivity analysis.The primary outcome Complications will be based solely on the specific assessment in the GynOp quality registry. The Clavien-Dindo classification will be evaluated as a secondary outcome.Furthermore, MRS is also measured three years postoperatively to better pinpoint the onset of menopausal symptoms.Discussion The changes to the protocol mainly concern the analyses of data. No changes to recruitment, randomization, intervention, or follow-up of primary outcomes have been made. An interim analysis during 2021 concluded that the study should continue until the target sample size is reached.

Subject headings and genre

MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine hsv//eng
MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Reproduktionsmedicin och gynekologi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Obstetrics, Gynaecology and Reproductive Medicine hsv//eng
HOPPSA
Opportunistic salpingectomy
Hysterectomy
Complications
Menopausal symptoms
Ovarian cancer
Complications

Added entries (persons, corporate bodies, meetings, titles ...)

Liv, Per,1979-Umeå universitet,Institutionen för folkhälsa och klinisk medicin(Swepub:umu)perliv00 (author)
Darelius, AnnaGothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för obstetrik och gynekologi,Institute of Clinical Sciences, Department of Obstetrics and Gynecology,Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden(Swepub:gu)xdarea (author)
Collins, ElinUmeå universitet,Obstetrik och gynekologi(Swepub:umu)elnsjm01 (author)
Sundfeldt, Karin,1962Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för obstetrik och gynekologi,Institute of Clinical Sciences, Department of Obstetrics and Gynecology,Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden(Swepub:gu)xsukar (author)
Pålsson, Mathias,1969Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för obstetrik och gynekologi,Institute of Clinical Sciences, Department of Obstetrics and Gynecology,Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden(Swepub:gu)xpalsm (author)
Strandell, Annika,1956Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för obstetrik och gynekologi,Institute of Clinical Sciences, Department of Obstetrics and Gynecology,Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden(Swepub:gu)xsannb (author)
Umeå universitetObstetrik och gynekologi (creator_code:org_t)

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In:Trials: Springer Science and Business Media LLC24:11745-6215

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