Laparoscopic Radiofrequency Ablation VS Laparoscopic Myomectomy in the Treatment of Symptomatic Uterine Leiomyomas: A Meta-Analysis of Randomized Controlled Trials

Author(s)

Rane A1, Pohlman S2
1Hologic, Inc., Arlington, MA, USA, 2Hologic, Inc., Marlborough, MA, USA

Presentation Documents

OBJECTIVES: This meta-analysis reviews the evidence from randomized controlled trials (RCTs) which compare laparoscopic radiofrequency ablation (LAP-RFA) and laparoscopic myomectomy (LM), two uterine sparing procedures for managing symptomatic uterine leiomyomas (UL).

METHODS: A comprehensive search was performed on PubMed, EMBASE®, and Cochrane Library through October 2020. The inclusion criteria were RCTs comparing LAP-RFA with LM in women with UL. RCTs comparing LAP-RFA with other treatments were excluded. Outcomes of interest were changes in quality of life (QOL) measures such as EQ-5D, uterine fibroid symptom QOL (UFSQOL), health-related QOL (HRQOL) and clinical endpoints such as mean operative blood loss (MOBL), length of hospital stay (LOS), and mean number of fibroids excised. Fixed-effects (FE) and random-effects (RE) models were used to quantify pooled effectiveness of LAP-RFA vs LM. Mean difference (MD), 95% CI, p-value were computed for clinical endpoints using R software (2020).

RESULTS: A total of 579 citations were found and after removing the duplicates, 495 title and abstracts were screened for eligibility. Four studies were eligible for qualitative review and 2 studies (LUSTOR Germany, and TRUST Canada) reporting the results of 96 total patients (47 Lap-RFA, 49 LM), met the inclusion criteria. Improvement in QOL endpoints were similar for Lap-RFA and LM (EQ-5D: p=0.8750, UFSQOL: p=0.7019, HRQOL: p=0.6220). LAP-RFA reduced MOBL compared to LM with statistical significance (FE: MD=-43.93 ml (95% CI: -61.42, -26.45, p<0.001); RE: MD=-44.64 ml (95% CI: -66.21, -23.08; p<0.001)). Moreover, LAP-RFA also reduced the LOS postoperatively compared to LM (FE: MD=-9.47 hours (95% CI: -13.13, -5.81, p<0.001); RE: MD=-11.44 hours (95% CI: -27.80, 4.93; p>0.1707)). Overall, LAP-RFA treated more fibroids than LM but the results were not statistically significant (RE: MD=0.72 (95% CI: -0.17, 1.61; p>0.114).

CONCLUSIONS: LAP-RFA was associated with shorter LOS, lower MOBL and similar QOL outcomes compared to LM.

Conference/Value in Health Info

2021-05, ISPOR 2021, Montreal, Canada

Value in Health, Volume 24, Issue 5, S1 (May 2021)

Code

PMD2

Topic

Clinical Outcomes, Medical Technologies

Topic Subcategory

Clinical Outcomes Assessment, Clinician Reported Outcomes, Comparative Effectiveness or Efficacy, Medical Devices

Disease

Medical Devices

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