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HysNiche

 

Hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomized controlled trial

 

Go to the HysNiche website

 

Rationale

In western countries, caesarean rates are rising. A caesarean section can cause a niche (defect at the site of the uterine scar); the incidence of niche related postmenstrual spotting in the Netherlands is expected to be 4100 per year. Promising results are reported after an innovative minimally invasive hysteroscopic resection of these niches. However its (cost) effectiveness in comparison to a control group has to be proven.


Objective
Our primary objective is to study the effectiveness of hysteroscopic resection for niche related uterine bleeding disorders. Our secondary objective is to assess the quality of life, sexual function and cost-effective analysis will be made.

Study design
Multicenter randomized trial


Study population
Women with post-menstrual uterine spotting and a niche with sufficient residual myometrium (at least 3mm) without any other intra-uterine disorders.


Intervention

Patients with a niche will be randomly allocated to hysteroscopic resection or expectant management.

 

Outcome measures

Primary outcome

The total number of days with postmenstrual spotting.

 

Secondary outcomes

Menstrual pattern (score card) and related pain (VAS) and disturbance (VAS), Quality of life (AMSS, SF36, EuroQol), patient satisfaction, and sexual function (QSD) after 3 months. Medical consultation and medication use, complications, sick leave, and costs (diary) during first 3 months and after 12 months.

Power/data analysis
Assuming a difference in 2 days and SD of 2.7, an alpha of 0.05, a dropout rate of 20%, using student t-test for independent samples, two sided, we need to include 50 patients in each arm to achieve a power of 90%.

Time schedule
Inclusion period 12 months, follow up period 12 months.

Projectleaders
Dr. J.A.F. Huirne, Gynaecologist VUmc


Health Technology Assessment

Drs. M.J. Witmer , MD, PHd-student VUmc


Subsidy
Zonmw

 

Contact

Machteld Witmer arts-onderzoeker Gynaecologie VU-medisch centrum

Contact: hysniche@studies-obsgyn.nl

Tel 020-4443613