Laparoscopic hysterectomy versus open abdominal hysterectomy for women with a benign gynaecological condition: the LAVA RCT

Background
The comparative rates of major complications and recovery times between laparoscopic hysterectomy and abdominal hysterectomy for benign gynaecological conditions remain uncertain.

Objective(s)
To assess the clinical and cost-effectiveness of laparoscopic hysterectomy compared to abdominal hysterectomy in women with benign gynaecological conditions.

Design and methods
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, and a post-closure survey after recruitment ended.

Setting and participants
Women in secondary care requiring hysterectomy and eligible for either surgical method.

Interventions
Laparoscopic hysterectomy versus abdominal hysterectomy.

Main outcome measures
The primary outcome was major complications (Clavien–Dindo ≥ level III) up to 6 completed weeks post surgery, and the key secondary outcome was time from surgery to resumption of usual activities using the personalised Patient-Reported Outcomes Measurement Information System Physical Function questionnaire. The principal outcome for the economic evaluation was to be cost per quality-adjusted life-year at 12 months post surgery and was feasibility and acceptability for the qualitative process evaluation.

Results
Two hundred and fifty-two patients were screened from 13 open sites over 13 months, 156 (62%) were eligible and 75 (49%) randomised. Of the 53 women not randomised, 23 (43%) preferred laparoscopic hysterectomy and 6 (11%) abdominal hysterectomy. About 32/39 (82%) and 30/36 (83%) participants randomised to laparoscopic hysterectomy and abdominal hysterectomy, respectively, had their surgery, of which 31/32 (97%) and 25/30 (83%) received their allocated route of hysterectomy. Major complications occurred in 2/32 (6%) laparoscopic hysterectomy versus 4/30 (13%) abdominal hysterectomy groups. There was no difference in time to resumption of activities [median (interquartile range, N) 7.5 weeks (3.6–8.2, 25) laparoscopic hysterectomy vs. 7.5 weeks (5.5–10.6, 26) abdominal hysterectomy groups] or quality of recovery [mean (standard deviation, N) 81.1 (13.4, 27) vs. 72.3 (17.6, 22) respectively; adjusted mean difference 7.2, 95% confidence interval −3.2 to 17.6]. The qualitative evaluation found that the trial was viewed positively by women and healthcare professionals. The reasons for failure to recruit from 21 sites open or in set-up were lack of research/clinical capacity imposed by the COVID-19 pandemic (14, 67%) and lack of clinician equipoise (11, 52%).

Limitations
The main limitation was failure to recruit, resulting in a final sample of 75 patients from a target of 3250. At the time of analysis, 13 (17%) randomised patients had not had surgery, and 6 (8%) did not adhere to the allocated route of hysterectomy. The planned health economic evaluation could not be performed.

Conclusions
The LAVA trial was acceptable for women and healthcare professionals but closed early due to the adverse impact of the COVID-19 pandemic and a lack of clinician equipoise. No significant differences in complications or recovery between laparoscopic hysterectomy and abdominal hysterectomy were observed. However, early trial cessation because of recruitment challenges limit inferences. Future large-scale trials are important, especially as laparoscopic hysterectomy and robotic techniques become standard. Success will depend on innovative trial designs and strategies that engage clinicians and research departments.

Future work
Lessons learnt from the failed LAVA trial should be used to inform the management and designs of future studies in benign gynaecological surgery.