Authors' objectives: The comparative rates of major complications and recovery times between laparoscopic hysterectomy and abdominal hysterectomy for benign gynaecological conditions remain uncertain. To assess the clinical and cost-effectiveness of laparoscopic hysterectomy compared to abdominal hysterectomy in women with benign gynaecological conditions.

Authors' results and conclusions: 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%). 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.

Authors' 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. Women in secondary care requiring hysterectomy and eligible for either surgical method. Laparoscopic hysterectomy versus abdominal hysterectomy. 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. 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.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/NIHR128991

Year Published: 2026

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/published-articles/GJTC1718

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/GJTC1718

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk