LAVA -Laparoscopic versus Abdominal hysterectomy trial
Research type
Research Study
Full title
LAparoscopic Versus Abdominal hysterectomy (LAVA) trial
IRAS ID
287988
Contact name
Birgit Whitman
Contact email
Sponsor organisation
University of Birmingham
ISRCTN Number
ISRCTN14566195
Duration of Study in the UK
5 years, 2 months, 30 days
Research summary
This study will compare the severity and rate of complications experienced by women who are having a hysterectomy for a benign condition by either an open (cut in the abdomen) or through a keyhole (laparoscopic) route. The side effects from cutting open the abdomen such as infection and pain have meant that women having an open hysterectomy need to stay in hospital longer than women having keyhole surgery. Women having their hysterectomy through an open cut often take longer to recover compared with women who’ve had their operations via the keyhole route. Many people believe that keyhole surgery takes longer to do than an open operation and the surgeon needs to be a specialist to do the keyhole operation. Low-quality evidence suggested that women who have their wombs removed via the keyhole route may have more bladder and waterworks problems than women who’ve had their operation via the traditional open route. However, since these studies were done the surgical equipment used for keyhole surgery has got better and more surgeons have done more keyhole techniques during their training and once they specialise. As such an open route may not be better than a keyhole route any longer. LAVA is a randomised study and will look at complications experienced by women who have their wombs removed by either an open or keyhole route, as well as looking how long they take to recover, women will be randomised to either a laparoscopic or abdominal hysterectomy. It will look at the longer term outcomes of the procedures to see how women feel about their lives up to 15 months, as well as if the woman needed to go back for further treatment after her operation.
An embedded qualitative study will explore women's and healthcare professionals' views and experiences of all aspects of the trial.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0019
Date of REC Opinion
19 Feb 2021
REC opinion
Further Information Favourable Opinion