Totally Enclosed Protective Device versus Conventional Retrieval Bag in Laparoscopic Ovarian Teratoma Cystectomy: A Multicenter Randomized Controlled Trial.
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引用次数: 0
Abstract
Objective: To evaluate a "Totally Enclosed Protective Device" in preventing macroscopic intraoperative leakage during laparoscopic ovarian cystectomy compared to conventional methods.
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.
期刊介绍：
The Journal of Minimally Invasive Gynecology, formerly titled The Journal of the American Association of Gynecologic Laparoscopists, is an international clinical forum for the exchange and dissemination of ideas, findings and techniques relevant to gynecologic endoscopy and other minimally invasive procedures. The Journal, which presents research, clinical opinions and case reports from the brightest minds in gynecologic surgery, is an authoritative source informing practicing physicians of the latest, cutting-edge developments occurring in this emerging field.
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