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- Magarakis, LeonidasGothenburg 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, University of Gothenburg, Gothenburg, Sweden (author)
SALpingectomy for STERilisation (SALSTER): study protocol for a Swedish multicentre register-based randomised controlled trial.
- Article/chapterEnglish2023
Publisher, publication year, extent ...
- BMJ Publishing Group Ltd,2023
Numbers
- LIBRIS-ID:oai:gup.ub.gu.se/331742
- https://gup.ub.gu.se/publication/331742URI
- https://doi.org/10.1136/bmjopen-2022-071246DOI
- https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-214288URI
Supplementary language notes
- Language:English
Part of subdatabase
- SwePubSwePub
Classification
Notes
- Salpingectomy is currently suggested as an alternative to tubal ligation for sterilisation. Precursor lesions of ovarian carcinoma can be found in the fallopian tubes; thus, salpingectomy could possibly reduce the incidence. Most of the existing trials on safety are small, on caesarean section and report on surrogate ovarian function measures. Randomised trials in laparoscopy are lacking. Well-designed trials are needed to evaluate safety of laparoscopic opportunistic salpingectomy.In SALSTER, a national register-based randomised controlled non-inferiority trial, 968women <50 years, wishing laparoscopic sterilisation will be randomised to either salpingectomy or tubal ligation. The Swedish National Quality Register of Gynecological Surgery (GynOp) will be used for inclusion, randomisation and follow-up. Primary outcomes are any complication up to 8weeks postoperatively, and age at menopause. Both outcomes are measured with questionnaires, complications are also assessed by a gynaecologist. In a nested trial, ovarian function will be evaluated comparing the mean difference of anti-Müllerian hormone (AMH), assessed preoperatively and 1year after surgery.Performing salpingectomy for sterilisation has become increasingly common, despite the unclear risk-benefit balance. SALSTER studies the safety of salpingectomy compared with tubal ligation. Regardless of the result, SALSTER will provide gynaecologists with high quality evidence to inform women to decide on salpingectomy or not. The central ethical review board of Gothenburg, Sweden (Dnr. 316-18) approved the trial in 2018. Results will be presented at scientific congresses and published in peer-reviewed scientific journals. The results will be communicated through professional organisations and research networks.NCT03860805.
Subject headings and genre
- MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Reproduktionsmedicin och gynekologi hsv//swe
- MEDICAL AND HEALTH SCIENCES Clinical Medicine Obstetrics, Gynaecology and Reproductive Medicine hsv//eng
- Female
- Humans
- Pregnancy
- Cesarean Section
- Multicenter Studies as Topic
- Ovarian Neoplasms
- prevention & control
- surgery
- Randomized Controlled Trials as Topic
- Salpingectomy
- Sterilization
- Sweden
- Adult
- Gynaecological oncology
Added entries (persons, corporate bodies, meetings, titles ...)
- Idahl, Annika,1965-Umeå universitet,Obstetrik och gynekologi(Swepub:umu)anid0002 (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, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Gothenburg, Sweden(Swepub:gu)xsukar (author)
- Liv, Per,1979-Umeå universitet,Institutionen för folkhälsa och klinisk medicin(Swepub:umu)perliv00 (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, 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, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Gothenburg, Sweden(Swepub:gu)xsannb (author)
- Göteborgs universitetInstitutionen för kliniska vetenskaper, Avdelningen för obstetrik och gynekologi (creator_code:org_t)
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