子宮内膜症に対するアブレーション手技の組織学的比較：ランダム化試験

To compare ablative energy technologies and evaluate their ability to destroy in vivo endometriosis tissue in humans.

Prospective, randomized, triple-arm, single-blind, clinical trial.

Good Samaritan Hospital, Cincinnati, Ohio.

Women undergoing excision of lesions for pelvic pain symptoms or endometriosis by a high-volume minimally invasive gynecologic surgeon.

During the already planned excision of lesions, just prior to excision, identified lesions were uniquely numbered and randomized to ablative treatment with either 1) electrical diathermy, 2) Argon beam coagulation, or 3) CO₂ laser. The lesions were ablated with the assigned technologies. Excision of the ablated lesions was then performed for pathologic evaluation.

The primary outcome was the frequency of positive histology for endometriosis within the ablated surgical specimens. Sample size was calculated in advance to be 140 samples, which would provide power of 0.8 and significance of 0.0167. A total of 153 samples of ablated lesions were excised and collected from a total of 34 patients, with 51 samples in each of the three surgical technology arms. Overall, 20 (13%) of the ablated lesions still contained endometriosis identified on pathology after subsequent excision. Stratified by treatment arm, the numbers of specimens that remained endometriosis-positive after ablative treatment were 10 (20%) for electrical diathermy, 4 (8%) for Argon beam coagulation, and 6 (12%) for CO₂ Laser (p=0.20).

No difference was detected in comparing the histologic effectiveness of Diathermy, CO₂ laser, and Argon, when used to destroy endometriosis. Excision is able to remove disease left behind after ablation.

NCT06414083. Registered Date May 09, 2024.