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AnteayerBMJ Open

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

Por: Antoun · L. · Woolley · R. · Middleton · L. · Smith · P. · Saridogan · E. · Cooper · K. · McKinnon · W. · Bevan · S. · Ziomek · K. · Sairally · Z. · Jones · L. · Fullard · J. · Morgan · M. · Clark · T. J.
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.

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