Comparison of complications and recovery after laparoscopic and abdominal hysterectomy for benign disease: the LAparoscopic Versus Abdominal hysterectomy (LAVA) randomised controlled trial

Abstract

OBJECTIVE: To compare recovery after laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH). DESIGN: A parallel, open, non-inferiority, multicentre, randomised controlled, expertise-based surgery trial. SETTING: 10 NHS (National Health Service) hospitals within the UK. PARTICIPANTS: Women undergoing hysterectomy for a benign gynaecological condition. INTERVENTIONS: Consenting women of 18-55 years were randomised to LH or AH using a secure internet facility by a surgeon with self-declared expertise. Major complications were recorded by clinicians, and recovery was assessed by regular text messaging and postal questionnaires. PRIMARY AND SECONDARY OUTCOME MEASURES: Major surgical complications (Clavien-Dindo≥level 3) up to six completed weeks postsurgery, time to resumption of normal activities measured by the Patient-Reported Outcomes Measurement Information System Physical Function tool and quality of recovery at 24 hours (Quality of Recovery 15 score; 0-150). RESULTS: 75 women were randomised before early curtailment of the trial; 32/39 (82%) and 30/36 (83%) women underwent LH and AH, respectively. Major complications occurred in 2/32 (6%) LH versus 4/30 (13%) AH groups. No difference in time to resumption of usual activities was found (median [IQR, n] 7.5 weeks (3.6-8.2, 25) LH vs 7.5 weeks (5.5-10.6, 26) AH groups or quality of recovery (mean [SD, n] 81.1 (13.4, 27) vs 72.3 (17.6, 22), respectively; adjusted mean difference 7.2, 95% CI -3.2 to 17.6). CONCLUSIONS: No differences were found in complications or recovery between LH and AH. However, early cessation of the trial due to recruitment challenges limits clinical inferences. It is important that larger comparative trials are conducted now that LH, including robotics, is becoming adopted as standard practice. TRIAL REGISTRATION NUMBER: ISRCTN14566195, IRAS ID 287988.