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

Abstract

BackgroundA 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/DesignWe 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.DiscussionThis 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 registrationDutch Trial Register NTR3269. Registered 1 February 2012. ZonMw Grant number 80-82305-97-12030

Laparoscopic repair with hysteroscopy of cesarean scar diverticulum

“…However, because suture is not possible with hysteroscopy, CSD would be enlarged and the myometrial thickness at the level of the uterine isthmus would be further decreased. Also, this treatment has a risk of bladder injury and uterine perforation while applying thermal energy to the scar. Furthermore, this technique could increase the risk of uterine rupture during a subsequent pregnancy, and recurrences are still possible in the long term.…”

Hysteroscopic resection of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial

“…The lower rim of the niche, if prominently visible, was resected as described by Chang et al and Fabres et al14, 17 The niche surface was superficially coagulated with the use of a rollerball (Figures 1 and S2). 24 …”

“…Three months after randomisation niche depth and residual myometrium were measured by transvaginal sonography according to a standardised method 24. Women were offered to undergo sonohysterography; however, this was omitted if women refused.…”

“…A niche was defined as an indentation in the uterine wall at the site of the caesarean scar with a depth of at least 2 mm, measured during sonohysterography according to a standardized protocol ( Figure S1). 24 Exclusion criteria included being under the age of 18 years, pregnancy, (suspected) malignancies, absence of cyclic bleeding periods caused by a levonorgestrel intrauterine device (IUD), continuous oral contraceptives or gonadotropin-releasing hormone (GnRH) agonists, contraindications for spinal or general anaesthesia, atypical endometrial cells or cervical dysplasia in cervical cytology, uterine or cervical polyps, submucosal fibroids, cervical or pelvic infection in the cervical swab, a hydrosalpinx that communicates with the uterus, or an irregular cycle (>35 days or with an intercycle variation of 2 weeks or more). The absence of cyclic bleeding as a result of hormonal treatments was defined in the study protocol from the start of the study as an exclusion criterion, but was erroneously not reported in the published study protocol.…”

Incidental Findings of Caesarean Section Scar Defect - Case Reports and a Review of its Investigations and Management

“…For patients with CSD presenting with postmenstrual spotting and pain, hysteroscopic resection of the CSD niche at the time of hysteroscopic evaluation may result in alleviation of symptoms. Vervoort et al, reported a multicentre randomised trial (Dutch Trial NTR3269 -registered in February 2012) that might provide evidence on the cost effectiveness of hysteroscopic resection versus expectant management for symptomatic patients [10]. A conclusion drawn on the cost effectiveness analysis is expected to be available to guide the management of symptomatic patients who have no desire for pregnancy by the end of the trial.…”