Comparison of GnRH analogue and tourniquet on blood loss in myomectomy
Research type
Research Study
Full title
A randomised controlled trial to investigate the effect of pre-operative GnRH analogues and intra-operative mechanical tourniquets for myomectomy on intra-operative blood loss and future fertility
IRAS ID
42372
Contact name
Nitish Narveka
Sponsor organisation
Research and Development Manager
Eudract number
2010-019810-26
ISRCTN Number
No number provided
Clinicaltrials.gov Identifier
No number provided
Research summary
Fibroids are extremely common benign (not cancer) tumours of the womb (uterus). They usually affect women age of child-bearing age (15-50) and present a large burden to patients and the NHS. They are more common in Black women, who are also more likely to have multiple, larger fibroids. Myomectomy (removal of fibroids by major operation) is the treatment of choice for women wishing to preserve the function of the womb and have a child in the future. The most significant risk of myomectomy is bleeding during the operation, especially in women with large or multiple fibroids. At present woman are given a hormone injection (GnRH analogue) before the operation to shrink the fibroids, or have a rubber tube (tourniquet) tied at the bottom of the womb to stop blood entering the womb. Occasionally both of these interventions will be used together. We do not know which intervention is more effective at limiting blood loss, especially when a woman has a large womb with lots of fibroids.We aim to compare the investigate the effectiveness of these interventions on reducing blood loss during myomectomy. We will also investigate any short and long term adverse effect they may have on a woman's quality of life and fertility.We aim to recruit 120 women who will be followed up for 24 months
REC name
London - Dulwich Research Ethics Committee
REC reference
10/H0808/62
Date of REC Opinion
2 Sep 2010
REC opinion
Further Information Favourable Opinion