Comparison of VCare and SecuFix uterine manipulator in total laparoscopic hysterectomy: a prospective randomized trial.

IF 1 Ginekologia polska Pub Date : 2025-01-01 Epub Date: 2025-02-11 DOI:10.5603/gpl.101589
Emre Mat, Esra Keles, Pınar Yıldız, Murat Levent Dereli, Fatih Şanlıkan, Gazi Yıldız
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Abstract

Objectives: To compare the Vcare and SecuFix uterine manipulators (UM) used in total laparoscopic hysterectomy (TLH) with regard to operating time, duration of hospital stay, the time for insertion of the manipulator, time for completion of colpotomy, and maintenance of pneumoperitoneum, estimated blood loss, and perioperative complications.

Material and methods: This prospective, single-center, randomized controlled trial was conducted on patients who underwent TLH for benign indications between June 2023 and January 2024. Patients were randomized to either the Vcare UM or SecuFix UM group. Both groups were compared for operative time, colpotomy time, intrauterine manipulator insertion time, pneumoperitoneum maintenance, blood loss, complications, and length of hospital stay.

Results: A total of 100 patients were enrolled, 50 with VcareUM and 50 with SecuFix UM. SecuFix UM demonstrated shorter colpotomy time (p < 0.001) and better pneumoperitoneum maintenance (p = 0.008) compared to VCare. VCare had shorter insertion time (p = 0.001) but a higher uterine rupture rate (p = 0.001). No significant differences were found in operative time, blood loss, complications, or length of hospital stay (p > 0.05).

Conclusions: SecuFix may offer advantages in colpotomy and pneumoperitoneum maintenance during TLH compared to VCare. The Vcare UM demonstrated a shorter insertion time than the SecuFix UMs, yet a higher rate of uterine rupture was observed with its placement.

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VCare和SecuFix子宫操纵器在腹腔镜全子宫切除术中的比较:一项前瞻性随机试验。
目的:比较全腹腔镜子宫切除术(TLH)中使用的Vcare和SecuFix子宫机械手(UM)在手术时间、住院时间、机械手插入时间、完成阴道切开时间、气腹维持时间、估计失血量和围手术期并发症等方面的差异。材料和方法:这项前瞻性、单中心、随机对照试验在2023年6月至2024年1月期间对因良性适应症接受TLH的患者进行了研究。患者随机分为Vcare UM组和SecuFix UM组。比较两组患者手术时间、阴道切开时间、宫内机械手插入时间、气腹维持时间、出血量、并发症、住院时间。结果:共纳入100例患者,50例使用VcareUM, 50例使用SecuFix UM。与VCare相比,SecuFix UM表现出更短的阴道切开时间(p < 0.001)和更好的气腹维持(p = 0.008)。VCare的插入时间较短(p = 0.001),但子宫破裂率较高(p = 0.001)。两组手术时间、出血量、并发症、住院时间差异无统计学意义(p < 0.05)。结论:与VCare相比,SecuFix在TLH期间的阴道切开和气腹维持方面可能具有优势。Vcare的插入时间比SecuFix的短,但其放置的子宫破裂率更高。
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