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, L. F. Van der Voet, M. Witmer, A. L. Thurkow, C. M. Radder, P. J M van Kesteren, H. W P Quartero, W. K H Kuchenbecker, M. Y. Bongers, P. M A J Geomini, L. H M de Vleeschouwer, M. H A van Hooff, H. A A M van Vliet, S. Veersema, W. B. Renes, H. S. van Meurs, J. Bosmans, K. Oude Rengerink, H. A M Brölmann, B. W J MolJ. A F Huirne

Research output: Contribution to journalArticle

17 Citations (Scopus)

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/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.

Original languageEnglish
Article number103
JournalBMC Women's Health
Volume15
Issue number1
DOIs
Publication statusPublished - 12 Nov 2015

Keywords

  • Abnormal uterine bleeding
  • Caesarean section
  • Hysteroscopic resection
  • Niche
  • Postmenstrual spotting
  • Scar defect

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynaecology

Cite this

Vervoort, A. J. M. W., Van der Voet, L. F., Witmer, M., Thurkow, A. L., Radder, C. M., van Kesteren, P. J. M., ... 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, 15(1), [103]. https://doi.org/10.1186/s12905-015-0260-8