Journal of minimally invasive gynecology · 2026
Totally Enclosed Protective Device versus Conventional Retrieval Bag in Laparoscopic Ovarian Teratoma Cystectomy: A Multicenter Randomized Controlled Trial.
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Zhou Chang, Hou Shengdi, Yu Huan, Liu Qing, Meng Yuanguang, Duan Hua, Liang Haiyan, Rong Chunhong, Zhao Fang, Yang Yanjun, Liu Ying, He Guifang, Chen Qingyun, Li Xiulan, Yang Wen, Chang Yanan, Wang Wenhui, Liang Jing, Feng Dingqing, Ling Bin
Аннотация
OBJECTIVE: To evaluate a "Totally Enclosed Protective Device" in preventing macroscopic intraoperative leakage during laparoscopic ovarian cystectomy compared to conventional methods.
DESIGN: Prospective, multicenter, randomized controlled superiority trial (1:1).
SETTING: Four academic medical centers in Beijing, China.
PARTICIPANTS: 119 premenopausal women (18-45 years) scheduled for laparoscopic cystectomy for unilateral ovarian masses (3-10 cm) were randomized. After exclusions, 105 participants (intervention: 53; control: 52) were analyzed.
INTERVENTIONS: Laparoscopic cystectomy using the device for contained decortication/extraction, versus conventional decortication followed by standard retrieval bag extraction.
MEASUREMENTS AND MAIN RESULTS: Device deployment success was 100%. Macroscopic leakage (primary outcome) was significantly lower in the intervention group (0.0%, 0/53) than controls (25.0%, 13/52) (risk difference [RD], -25.0%; 95% CI, -36.8% to -13.2%; P<0.001). Intraoperative rupture rates were comparable (32.1% vs. 25.0%; RD, 7.1%; 95% CI, -10.3% to 24.5%; P=0.422). Operative times were similar. Over a 34.5-month median follow-up, 5 control patients (9.6%) developed new-onset chronic pelvic pain, versus 0 in the intervention group.
CONCLUSION: Within this study cohort, the device provided an effective physical barrier, and no macroscopic intraoperative spillage was observed. Preliminary findings suggest that standardizing this contained extraction strategy is associated with the absence of long-term complications, specifically chronic pelvic pain, in this sample.
FUNDING: This study was supported by Capital's Funds for Health Improvement and Research (No. 2022-2-406).
CLINICAL TRIAL REGISTRATION: Registration Number: NCT04406597; Date of Registration: May 20, 2022.
DESIGN: Prospective, multicenter, randomized controlled superiority trial (1:1).
SETTING: Four academic medical centers in Beijing, China.
PARTICIPANTS: 119 premenopausal women (18-45 years) scheduled for laparoscopic cystectomy for unilateral ovarian masses (3-10 cm) were randomized. After exclusions, 105 participants (intervention: 53; control: 52) were analyzed.
INTERVENTIONS: Laparoscopic cystectomy using the device for contained decortication/extraction, versus conventional decortication followed by standard retrieval bag extraction.
MEASUREMENTS AND MAIN RESULTS: Device deployment success was 100%. Macroscopic leakage (primary outcome) was significantly lower in the intervention group (0.0%, 0/53) than controls (25.0%, 13/52) (risk difference [RD], -25.0%; 95% CI, -36.8% to -13.2%; P<0.001). Intraoperative rupture rates were comparable (32.1% vs. 25.0%; RD, 7.1%; 95% CI, -10.3% to 24.5%; P=0.422). Operative times were similar. Over a 34.5-month median follow-up, 5 control patients (9.6%) developed new-onset chronic pelvic pain, versus 0 in the intervention group.
CONCLUSION: Within this study cohort, the device provided an effective physical barrier, and no macroscopic intraoperative spillage was observed. Preliminary findings suggest that standardizing this contained extraction strategy is associated with the absence of long-term complications, specifically chronic pelvic pain, in this sample.
FUNDING: This study was supported by Capital's Funds for Health Improvement and Research (No. 2022-2-406).
CLINICAL TRIAL REGISTRATION: Registration Number: NCT04406597; Date of Registration: May 20, 2022.