Title: LAparoscopic Versus Abdominal hysterectomy (LAVA) trial
Funder: Department of Health and Social Care

Abstract: Background to the research: _x000D_ A hysterectomy is the medical term for surgically removing the uterus (“womb”). There are many reasons for having this common operation. Most women have the procedure because of benign (i.e. non-cancerous) problems such as heavy periods or pain._x000D_ _x000D_ Traditionally, women undergoing a hysterectomy will have a large surgical incision (“cut”) to open the abdomen (“tummy”). This cut is usually horizontal just above the pubic hair line (a “bikini-line” incision) but sometimes a vertical cut from below the navel (“belly button”) is necessary. This type of hysterectomy is called an abdominal hysterectomy. In contrast, a laparoscopic hysterectomy avoids large incisions. The procedure involves ‘key-hole’ surgery, where a telescope is inserted through a small 1cm cut in the navel. Two to three further cuts of a similar size or smaller are then made to insert the equipment the surgeon needs to do the operation. Sometimes, the surgeon finds that it is not possible to do the operation safely this way and in this circumstance the laparoscopic procedure is changed to a conventional abdominal hysterectomy._x000D_ _x000D_ Previous studies comparing these two ways of performing a hysterectomy have found that the advantages of laparoscopic hysterectomy were a shorter stay in hospital, less pain, fewer wound infections and quicker recovery at home. However, laparoscopic surgery takes longer and accidental injury to the bladder or ureters (these are “pipes” that transport urine produced by the kidney into the bladder) is more likely compared to abdominal hysterectomy. For these reasons, despite the possible recovery advantages of laparoscopic hysterectomy, the uptake of this less invasive surgery has been lower than anticipated and abdominal hysterectomy is still used most frequently by gynaecologists. _x000D_ _x000D_ Since these earlier studies were done, there have been major advances in surgical equipment and also in the training of surgeons in ‘key-hole’ surgery. Many gynaecologists consider the previous findings to be out of date, arguing that the downsides of laparoscopic hysterectomy have now been offset by improvements in laparoscopic skills and technology. Thus, women are possibly being denied potential short and long-term recovery advantages of less invasive laparoscopic hysterectomy. _x000D_ _x000D_ We plan to do a study (known as a trial) where women willing to take part and who need a hysterectomy will be randomly allocated to either a laparoscopic or abdominal procedure. In this way we aim to see which is preferable in terms of major complications and return to normal activities. The trial will also evaluate other important patient outcomes such as quality of life, physical functioning, work participation and body image after hysterectomy as well as examine the cost-effectiveness for the NHS. _x000D_ _x000D_ Our research has been developed with involvement of members of the RCOG Women’s Voices group, the Hysterectomy Association, and the Birmingham Women’s Hospital Hysterectomy Focus Group._x000D_ _x000D_ We have developed a clear plan to share the results of this trial with relevant stakeholders including GPs, hospital doctors, professional societies, patient support groups, NHS policy makers and patients. The findings will be published in major medical journals, presented at national and international scientific meetings, and made available through links on the websites of RCOG and Hysterectomy charity websites.

Lay abstract: Research question _x000D_ What is the clinical and cost-effectiveness of laparoscopic hysterectomy compared to open abdominal hysterectomy for women with a benign gynaecological condition? _x000D_ _x000D_ Background_x000D_ Hysterectomy for benign conditions is common. Most are performed abdominally because this method is thought to minimise intra-operative complications. Laparoscopic, ‘key-hole’, hysterectomy avoids large surgical incisions, thereby speeding recovery but has been associated with serious complications and the need for specialist surgical skills. Scientific advances have made laparoscopic surgery easier as well as more accessible to general gynaecologists. Thus, it is unclear whether the wider adoption of contemporary laparoscopic hysterectomy can minimise morbidity, expedite recovery and improve clinical outcomes and potentially reduce costs compared to abdominal hysterectomy. _x000D_ _x000D_ Aims and objectives_x000D_ To compare laparoscopic hysterectomy with open, abdominal hysterectomy in terms of major intra-operative and post-operative complications. In addition, we aim to evaluate time from surgery to resumption of usual activities and the relative cost-effectiveness of the two approaches. _x000D_ _x000D_ Methods_x000D_ A parallel, open, multicentre, randomised controlled trial with integrated health economic evaluation and an internal pilot with an embedded qualitative process evaluation. Women with benign gynaecological conditions requiring a hysterectomy and who are suitable for either surgical technique, are eligible for inclusion. The intervention is laparoscopic hysterectomy and the comparator is open, abdominal hysterectomy._x000D_ _x000D_ Outcomes_x000D_ The primary outcome is major intraoperative and post-operative complications assessed at 6 weeks post-surgery. A key secondary outcome is time from surgery to resumption of usual activities. Other secondary outcomes include satisfaction, quality of life, bowel/bladder function, sexual activity, body image and work participation assessed at 15 months post-randomisation. The cost-effectiveness analysis will be based upon the primary outcome of cost per quality adjusted life year._x000D_ _x000D_ Timelines for delivery_x000D_ The trial will last for 63 months, incorporating 9 months for development of the trial infrastructure, a 9 month pilot phase with embedded qualitative process evaluation. If feasibility criteria are satisfied then the main trial will have a 27 month time-frame for recruitment, randomisation and follow up. A further 18 months will be required for final patient follow-up data gathering, cleaning, analysis, and report preparation._x000D_ _x000D_ Anticipated impact and dissemination_x000D_ If laparoscopic hysterectomy is non-inferior to abdominal hysterectomy in terms of major complications, and more effective in facilitating swifter recovery, as well as being cost-effective, then the wider adoption of less invasive hysterectomy for benign conditions will benefit affected women and the health service. If no benefit, or poorer outcomes are found, then women can choose the most appropriate method of hysterectomy and health service resources will be better allocated. _x000D_ _x000D_ The results will be shared with stakeholders including patients, doctors, professional societies, trial networks, patient support groups, and NHS policy makers. The findings will be published in major medical journals, presented in national scientific meetings and made available through links on the websites of health professional societies and national hysterectomy / gynaecology charities.

Research activity codes: 6.4 SURGERY
Health categories: RENAL AND UROGENITAL