title: The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Dutch Trial Register NTR3269 . Registered 1 February 2012. ZonMw Grant number 80-82305-97-12030.
authors.affiliation: Department of Obstetrics and Gynaecology, VU medical centre, Amsterdam, Netherlands. aj.vervoort@vumc.nl.
authors.forename: A J M W
authors.initials: AJ
authors.lastname: Vervoort
authors.affiliation: Department of Obstetrics and Gynaecology, Deventer Hospital, Deventer, Netherlands. l.f.vandervoet@dz.nl.
authors.forename: L F
authors.initials: LF
authors.lastname: Van der Voet
authors.affiliation: Department of Obstetrics and Gynaecology, VU medical centre, Amsterdam, Netherlands. m.witmer@vumc.nl.
authors.forename: M
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authors.lastname: Witmer
authors.affiliation: Department of Obstetrics and Gynaecology, Sint Lucas Andreas Hospital, Amsterdam, Netherlands. a.thurkow@slaz.nl.
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authors.initials: AL
authors.lastname: Thurkow
authors.affiliation: Department of Obstetrics and Gynaecology, Sint Lucas Andreas Hospital, Amsterdam, Netherlands. c.radder@slaz.nl.
authors.forename: C M
authors.initials: CM
authors.lastname: Radder
authors.affiliation: Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands. p.j.m.vankesteren@olvg.nl.
authors.forename: P J M
authors.initials: PJ
authors.lastname: van Kesteren
authors.affiliation: Department of Obstetrics and Gynaecology, Medical Spectrum Twente, Enschede, Netherlands. h.quartero@mst.nl.
authors.forename: H W P
authors.initials: HW
authors.lastname: Quartero
authors.affiliation: Department of Obstetrics and Gynaecology, Isala clinics, Zwolle, Netherlands. w.k.h.kuchenbecker@isala.nl.
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authors.initials: WK
authors.lastname: Kuchenbecker
authors.affiliation: Department of Obstetrics and Gynaecology, Maxima Medical Centre, Eindhoven, Netherlands. m.bongers@mmc.nl.
authors.forename: M Y
authors.initials: MY
authors.lastname: Bongers
authors.affiliation: Department of Obstetrics and Gynaecology, Maxima Medical Centre, Eindhoven, Netherlands. p.geomini@mmc.nl.
authors.forename: P M A J
authors.initials: PM
authors.lastname: Geomini
authors.affiliation: Department of Obstetrics and Gynaecology, Sint Fransiscus Gasthuis, Rotterdam, Netherlands. m.devleeschouwer@sfg.nl.
authors.forename: L H M
authors.initials: LH
authors.lastname: de Vleeschouwer
authors.affiliation: Department of Obstetrics and Gynaecology, Sint Fransiscus Gasthuis, Rotterdam, Netherlands. m.vanhooff@sfg.nl.
authors.forename: M H A
authors.initials: MH
authors.lastname: van Hooff
authors.affiliation: Department of Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, Netherlands. huib.v.vliet@catharinaziekenhuis.nl.
authors.forename: H A A M
authors.initials: HA
authors.lastname: van Vliet
authors.affiliation: Department of Obstetrics and Gynaecology, Sint Antonius Hospital, Nieuwegein, Netherlands. s.veersema@antoniusziekenhuis.nl.
authors.forename: S
authors.initials: S
authors.lastname: Veersema
authors.affiliation: Department of Obstetrics and Gynaecology, IJsselland hospital, Capelle a/d/ IJssel, Netherlands. wrenes@ysl.nl.
authors.forename: W B
authors.initials: WB
authors.lastname: Renes
authors.affiliation: Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands. h.s.vanmeurs@amc.uva.nl.
authors.forename: H S
authors.initials: HS
authors.lastname: van Meurs
authors.affiliation: Department of Health sciences and the EMGO Institute for Health and Care Research, VU University, Amsterdam, Netherlands. j.e.bosmans@vu.nl.
authors.forename: J
authors.initials: J
authors.lastname: Bosmans
authors.affiliation: Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands. k.ouderengerink@amc.uva.nl.
authors.forename: K
authors.initials: K
authors.lastname: Oude Rengerink
authors.affiliation: Department of Obstetrics and Gynaecology, VU medical centre, Amsterdam, Netherlands. h.brolmann@vumc.nl.
authors.forename: H A M
authors.initials: HA
authors.lastname: Brölmann
authors.affiliation: The Robinson Research Institute | School of Paediatrics and Reproductive Health University of Adelaide, Adelaide, Australia. ben.mol@adelaide.edu.au.
authors.forename: B W J
authors.initials: BW
authors.lastname: Mol
authors.affiliation: Department of Obstetrics and Gynaecology, VU medical centre, Amsterdam, Netherlands. j.huirne@vumc.nl.
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authors.initials: JA
authors.lastname: Huirne
mesh_terms: D002585:Cesarean Section / Q000009:adverse effects / Q000534:rehabilitation*; D002921:Cicatrix / Q000534:rehabilitation*; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D015907:Hysteroscopy / Q000706:statistics & numerical data*; D008796:Metrorrhagia / Q000517:prevention & control; D011788:Quality of Life; D014599:Uterus / Q000473:pathology / Q000601:surgery*