Recovery After Transcervical Fibroid Ablation Versus Minimally Invasive Myomectomy for Symptomatic Uterine Fibroids: A Randomised Controlled Trial.

OBJECTIVE

To evaluate early recovery outcomes with transcervical fibroid ablation (TFA) compared to minimally invasive myomectomy (MIM) in women with symptomatic uterine fibroids.

DESIGN

Randomised controlled trial.

SETTING

Tübingen University Hospital (Tübingen, Germany).

SAMPLE: Premenopausal women aged 18-50 years with symptomatic uterine fibroids.

METHODS

Participants were randomised to undergo TFA or MIM. The MIM group underwent laparoscopic myomectomy with concurrent hysteroscopic myomectomy if submucosal fibroids were present.

MAIN OUTCOME MEASURES: The primary endpoint was the time to return to normal activities. Secondary outcomes included procedure time, postprocedural pain, hospital discharge readiness, time to return to 10 additional activities of daily living, and adverse events. Clinical outcomes through 7 weeks of follow-up were reported. The primary endpoint was evaluated at p < 0.028 due to a pre-planned interim analysis; secondary outcomes were evaluated at p < 0.05.

RESULTS

Among 144 randomised patients, 119 provided follow-up data (58 TFA; 61 MIM). The primary endpoint was met with the median time to return to normal activities favouring TFA (5.5 vs. 13 days; log-rank p < 0.001). Procedure time (51 ± 21 vs. 95 ± 37 min; p < 0.001), postprocedural pain through discharge (all p < 0.01), opioid utilisation (25.9% vs. 49.2%, p = 0.009), and time to discharge readiness (22.9 ± 13.2 vs. 58.9 ± 33.1 h; p < 0.001) favoured TFA. Nine of 10 treatment recovery metrics statistically favoured TFA with none favouring MIM. One serious adverse event occurred in a patient treated with MIM (diagnostic laparoscopy for postoperative bleeding).

CONCLUSIONS

TFA offers a faster recovery than MIM for the treatment of symptomatic uterine fibroids, with a comparable short-term safety profile.

TRIAL REGISTRATION: This trial was prospectively registered on the German Clinical Trials Register; https://drks.de/search/de/trial/DRKS00028847.