The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial
| العنوان: | The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial |
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| المؤلفون: | Walter K. H. Kuchenbecker, Judith E. Bosmans, L. H. M. de Vleeschouwer, H.A.M. Brölmann, C. M. Radder, M. Witmer, M.H.A. van Hooff, W. B. Renes, H. A. van Vliet, Andreas L. Thurkow, Ben W.J. Mol, L. F. van der Voet, S. Veersema, J.A.F. Huirne, H. W. P. Quartero, Marlies Y. Bongers, H. S. van Meurs, K. Oude Rengerink, P. M. A. J. Geomini, A. J. M. W. Vervoort, P. J. M. van Kesteren |
| المساهمون: | Obstetrics and gynaecology, EMGO - Quality of care, ICaR - Ischemia and repair, Obstetrics and Gynaecology, Health Economics and Health Technology Assessment, EMGO+ - Quality of Care, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), Obstetrie & Gynaecologie, RS: GROW - Developmental Biology, RS: GROW - R4 - Reproductive and Perinatal Medicine |
| المصدر: | BMC Women's Health, 15:103. BioMed Central Vervoort, A J M W, van der Voet, L F, Witmer, M, Thurkow, A L, Radder, C M, van Kesteren, P J M, Quartero, H W P, Kuchenbecker, W K H, Bongers, M Y, Geomini, P M A J, de Vleeschouwer, L H M, van Hooff, M H A, van Vliet, H A A M, Veersema, S, Renes, W B, van Meurs, H S, Bosmans, J E, Rengerink, K O, Brölmann, H A M, Mol, B W J & Huirne, J A F 2015, ' The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial ', BMC Women's Health, vol. 15, 103 . https://doi.org/10.1186/s12905-015-0260-8 BMC Women's Health, 15(103). BioMed Central BMC Women's health, 15(1). BioMed Central BMC Women's Health BMC Women's Health, 15. BioMed Central Ltd |
| سنة النشر: | 2015 |
| مصطلحات موضوعية: | medicine.medical_specialty, Metrorrhagia, Cost-Benefit Analysis, Scar defect, medicine.medical_treatment, Reproductive medicine, Abnormal uterine bleeding, Hysteroscopy, Research Support, Postmenstrual spotting, law.invention, Menstruation, Cicatrix, Study Protocol, Patient satisfaction, SDG 3 - Good Health and Well-being, Randomized controlled trial, Quality of life, law, Obstetrics and Gynaecology, Niche, medicine, Journal Article, Humans, Caesarean section, Non-U.S. Gov't, Medicine(all), medicine.diagnostic_test, Cesarean Section, business.industry, Obstetrics, Research Support, Non-U.S. Gov't, Uterus, Obstetrics and Gynecology, General Medicine, Hysteroscopic resection, Surgery, Reproductive Medicine, Randomized Controlled Trial, Quality of Life, Female, medicine.symptom, business |
| الوصف: | BACKGROUND: A caesarean section (CS) can cause a defect or disruption of the myometrium at the site of the uterine scar, called a niche. In recent years, an association between a niche and postmenstrual spotting after a CS has been demonstrated. Hysteroscopic resection of these niches is thought to reduce spotting and menstrual pain. However, there are no randomised trials assessing the effectiveness of a hysteroscopic niche resection. METHODS/DESIGN: We planned a multicentre randomised trial comparing hysteroscopic niche resection to no intervention. We study women with postmenstrual spotting after a CS and a niche with a residual myometrium of at least 3 mm during sonohysterography. After informed consent is obtained, eligible women will be randomly allocated to hysteroscopic resection of the niche or expectant management for 6 months. The primary outcome is the number of days with postmenstrual spotting during one menstrual cycle 6 months after randomisation. Secondary outcomes are menstrual characteristics, menstruation related pain and experienced discomfort due to spotting or menstrual pain, quality of life, patient satisfaction, sexual function, urological symptoms, medical consultations, medication use, complications, lost productivity and medical costs. Measurements will be performed at baseline and at 3 and 6 months after randomisation. A cost-effectiveness analysis will be performed from a societal perspective at 6 months after randomisation. DISCUSSION: This trial will provide insight in the (cost)effectiveness of hysteroscopic resection of a niche versus expectant management in women who have postmenstrual spotting and a niche with sufficient residual myometrium to perform a hysteroscopic niche resection. TRIAL REGISTRATION: Dutch Trial Register NTR3269 . Registered 1 February 2012. ZonMw Grant number 80-82305-97-12030. |
| وصف الملف: | image/pdf |
| تدمد: | 1472-6874 |
| DOI: | 10.1186/s12905-015-0260-8 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e41cf782ac5f36633214df1c1159a0c0 https://research.vumc.nl/en/publications/b890da87-9448-4139-b1af-e36ab5a37e15 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....e41cf782ac5f36633214df1c1159a0c0 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14726874 |
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| DOI: | 10.1186/s12905-015-0260-8 |