Lessons learnt from the multi-centre LAparoscopic Versus Abdominal hysterectomy (LAVA) randomised controlled trial

Area of Science:

• Gynecology and Surgical Innovation
• Clinical Trial Management
• Patient-Centered Care

Background:

• The LAparoscopic Versus Abdominal hysterectomy (LAVA) trial, comparing laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH), was prematurely terminated due to futility.
• This study examines the operational challenges and lessons learned from the LAVA trial's premature closure.

Purpose of the Study:

• To investigate the perspectives and experiences of clinical and research staff.
• To identify potential barriers to trial participation and patient recruitment.

Main Methods:

• A descriptive analysis of trial progress and staff feedback was conducted.
• Data were gathered from transcribed conversations, emails, and calls with clinical/research staff.

Main Results:

• Recruitment challenges included long site activation times (253 days to opening) and slow first participant randomization (68 days).
• Of 265 screened patients, 75 were randomized; 53 were not, with 43% preferring LH and 11% preferring AH.
• Key barriers to recruitment and site activation were limited research capacity due to the COVID-19 pandemic and a lack of clinician equipoise.

Conclusions:

• The LAVA trial's failure was primarily attributed to a lack of surgeon equipoise and the detrimental effects of the COVID-19 pandemic on clinical and research services.
• Surgeon preference for laparoscopic hysterectomy did not align with patient preferences, with many favoring open procedures.