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Background: The LAparoscopic Versus Abdominal hysterectomy (LAVA) randomised controlled trial comparing laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH) closed prematurely on the grounds of futility. Here we identify the challenges faced and lessons learnt. Objectives: To explore the views and experiences of clinical/research staff in order to understand how these might act as barriers to trial participation and recruitment. Materials and Methods: Review of the trial progress and collation of the views and experiences of clinical/ research staff on all aspects of the trial. Data were collected from transcribed conversations, email, phone, or video conferencing interactions and analysed descriptively. Main outcome measures: Site set-up milestones, recruitment rates and reasons provided by clinical/research staff for site's declining to participate. Opinions, preferences and experiences of clinicians/researchers and challenges to participation and recruitment. Results: The mean time from initial site contact to opening was 253 days and 68 days to randomise their first participant. 265 patients were screened from 13 sites over 13 months, 154 were eligible, and 75 (59%) were randomised. Of the 53 not randomised, 23 (43%) women preferred LH whilst 6 (11%) preferred AH. The main reasons given for failure to recruit or activate set-up in the 21 sites open or in set-up, were lack of research/ clinical capacity imposed by the COVID-19 pandemic and lack of clinician equipoise. Conclusions: The main reasons for the LAVA trial failure were lack of equipoise amongst surgeons and the adverse impact of the COVID-19 pandemic on clinical/research services. What is new?: Surgeons' preference for laparoscopic hysterectomy is not shared by most patients. Many patients prefer an open hysterectomy to a laparoscopic one.
RESUMEN
BACKGROUND: Short-stay total laparoscopic hysterectomy (TLH) could lead to reduced hospital costs and decrease complications associated with hospitalisation such as hospital acquired-infection and venous thromboembolism. OBJECTIVE: To evaluate the feasibility, safety and patient satisfaction of a novel short 'less than 23-hour' stay TLH protocol. MATERIAL AND METHODS: Prospective cohort study, at Birmingham Women's Hospital, United Kingdom including eligible women undergoing TLH for benign indications or early stage cervical/endometrial cancer. MAIN OUTCOME MEASURES: Feasibility of discharge within 23-hours following TLH. Surgical complications and readmission rates were collected within 30-days of hysterectomy and patient's satisfaction was assessed at 6-weeks. RESULTS: Of the 128 eligible women, 104/128 women (81%) were discharged within 23-hours of admission, of which 62/104 or 60% (48.4% of the whole cohort) were discharged on the same day. Adenomyosis/fibroids, and previous caesarean sections were associated with a greater likelihood of stay beyond 23-hours (P<0.05). The overall complications rate was 13/128 (10%) with two grade-3 Clavien-Dindo intraoperative complications; one serosal bowel injury oversewn and one ureteric injury requiring reimplantation. The readmissions rate was 5/128 (4%). 94% of patients were 'happy' or 'very happy' with the pathway, although satisfaction was higher in short-stay patients (RR 1.2; 95% CI 0.95-1.94). CONCLUSION: Hospital discharge within 23-hours of TLH appears to be safe, feasible and acceptable to patients where a standardised, multidisciplinary care protocol is used. WHAT IS NEW?: Our study is the first prospective case series in the UK reporting the safety and acceptability for performing laparoscopic hysterectomy as a 23-hour day case procedure.