The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in XXXX with abnormal bleeding, a randomised controlled trial.

@entity1 @entity1867 @entity1834 @entity158
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 @entity1867 after a CS has been demonstrated. Hysteroscopic resection of these niches is thought to reduce spotting and @entity1834 . 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 @entity1 with @entity1867 after a CS and a niche with a residual myometrium of at least 3  mm during sonohysterography. After informed consent is obtained, eligible @entity1 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 @entity1867 during one menstrual cycle 6  months after randomisation. Secondary outcomes are menstrual characteristics, menstruation related @entity158 and experienced discomfort due to spotting or @entity1834 , quality of life, @entity1 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 @entity1 who have @entity1867 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.
