LAVA Trial

Lava-Trial-Logo

LAparoscopic Versus Abdominal hysterectomy (LAVA) trial.

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. This study 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. 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.

 

Design

LAVA is a parallel, open, non-inferiority, multicentre, randomised controlled, expertise-based surgery trial with integrated health economic evaluation and an internal pilot with an embedded qualitative process evaluation to assess the ability of the study to recruit and randomise. 

Aim of the Study

The primary aim of LAVA is to compare laparoscopic hysterectomy with open abdominal hysterectomy in terms of major intra-operative and post-operative complications (up to six weeks). Post-operative recovery will also be evaluated by measuring the time from surgery to resumption of usual activities.  

Setting

Recruitment to the LAVA study will take place in gynaecology departments (general and relevant specialist clinics including menstrual disorders and pelvic pain clinics, hysteroscopy and colposcopy services) in up to 50 NHS Hospitals within the UK. 

Target Population

Inclusion Criteria:

  • Aged between 18-55 years of age and able to give informed consent to participate
  • Have a benign gynaecological condition that is being treated with a hysterectomy
  • This hysterectomy can be undertaken by either a laparoscopic or open abdominal routes

Exclusion Criteria:

  • Women with suspected malignant disease of the genital tract
  • Women who require concomitant gynaecological surgery for bladder or other pelvic support
  • Women who require concomitant gynaecological surgery for excision of deep endometriosis that requires dissection of the pararectal space

Intervention

Participants will be randomly allocated to undergo their hysterectomy by either a laparoscopic or open abdominal route.

Measurement of outcomes

Main clinical objectives

To compare laparoscopic hysterectomy with open abdominal hysterectomy in terms of major intra-operative and post-operative complications (up to six weeks). Post-operative recovery will also be evaluated by measuring the time from surgery to resumption of usual activities.  

Economic objectives

To compare the relative cost effectiveness of laparoscopic hysterectomy with open abdominal hysterectomy in terms of cost per quality adjusted life year. Additional cost-effectiveness analyses will explore cost per major complication avoided and cost per return to normal activities. 

 Qualitative process evaluation objectives

  1. With women: to explore their views and experiences of the recruitment approach, randomisation, barriers and facilitators to participation, and acceptability of treatment allocations;
  2. with healthcare professionals: to explore their views and experiences of recruitment, randomisation, including perceived barriers and facilitators, equipoise, appropriateness and acceptability of treatment allocations, and perceptions of trial processes.

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