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

A.j.m.w Vervoort ,M Witmer,L H M De Vleeschouwer,W B Renes,P J M Van Kesteren,Sebastiaan Veersema ,M.h.a Van Hooff ,Katrien Oude Rengerink ,Hannah S Van Meurs ,H.w.p Quartero ,Judith E Bosmans ,Walter K H Kuchenbecker ,Lucy F Van Der Voet ,Celine M Radder ,Hans A.m Brölmann ,Ben Willem J Mol ,Huib A.a.m Van Vliet ,Andreas L Thurkow ,Peggy M.a.j Geomini ,Marlies Y Bongers ,Judith A.f Huirne

doi:10.1186/s12905-015-0260-8

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

Highlights

A caesarean section (CS) can cause a defect or disruption of the myometrium at the site of the uterine scar, called a niche
Sample size Based on a systematic review of the literature executed in 2011 we identified one relevant manuscript reporting on a reduction in postmenstrual abnormal uterine bloodloss (PAUB) with an estimated median reduction of 3.8 days after a hysteroscopic niche resection compared to baseline [27]
Only recently, we became aware of an association between niches in the CS uterine scar and bleeding disorders [5, 6, 9,10,11,12]

Summary

Discussion

We became aware of an association between niches in the CS uterine scar and bleeding disorders [5, 6, 9,10,11,12]. Postmenstrual spotting is present in approximately 20 % of women after a CS. Several innovative surgical therapies to reduce these complaints have been developed [26]. The least invasive surgical therapy is the hysteroscopic resection of the niche. Only a few studies reported on hysteroscopic resections. Success rates on reduction of postmenstrual spotting are high and no complications are reported [15, 18,19,20,21,22,23, 26, 27]. Follow-up or (validated) tools to measure outcomes are mostly not reported and sample sizes were small

Background

Methods/Design

Findings

Strengths and limitations