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手术能量设备(凯门鳄®)对老年子宫内膜癌患者的临床影响(方案编号:Cineca)

Clinical impact of surgical energy device (Caiman®) IN elderly patients with Endometrial Cancer (protocol ID: Cineca).

作者信息

Perelli Federica, Arcieri Martina, Restaino Stefano, Mattei Alberto, Gueli Alletti Salvatore, Gallotta Valerio, Scambia Giovanni, Innocenzi Chiara, Costantini Barbara, Vizzielli Giuseppe

机构信息

Pediatric Gynecology Unit, Meyer Children's Hospital IRCCS, Florence, Italy; Azienda USL Toscana Centro, Gynecology and Obstetrics Department, Santa Maria Annunziata Hospital, Florence, Italy.

Clinic of Obstetrics and Gynecology, "Santa Maria Della Misericordia" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.

出版信息

Eur J Surg Oncol. 2025 Jul;51(7):109982. doi: 10.1016/j.ejso.2025.109982. Epub 2025 Mar 25.

Abstract

STUDY OBJECTIVE

To investigate the clinical performance of the Caiman® energy device in class A radical laparoscopic hysterectomy (RLH) according to Querleu-Morrow classification, combined with bilateral salpingo-oophorectomy (BSO) and pelvic lymph node assessment in elderly patients with early-stage endometrial cancer (EC), specifically focusing on hemostatic effectiveness and safety.

DESIGN

Single-institution, prospective observational study.

SETTING

Gynecologic Oncology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

PATIENTS

Forty-three women over 65 years with FIGO stage IA or IB endometrioid EC were enrolled from September 2021 to August 2023.

INTERVENTIONS

Use of Caiman® energy device in RLH combined with BSO and pelvic lymph node assessment in elderly patients.

MEASUREMENTS

The primary endpoint was operative time, with secondary endpoints including perioperative outcomes and postoperative complications.

MAIN RESULTS

Results demonstrated a median surgical time of 135 min, with no significant intraoperative complications attributed to the Caiman® device. Postoperative complications were minimal, with no severe complications (Grade 4 or 5) and a median hospital stay of two days.

CONCLUSION

The study highlights the advantages of the Caiman® in enhancing surgical efficiency while minimizing risks for elderly patients, suggesting its potential for improving resource allocation and patient outcomes in oncologic surgery. The findings of this study suggest the feasibility of using the Caiman® device for surgical procedures in elderly patients with early-stage endometrial cancer. Future prospective randomized trials are needed to establish its efficacy compared to traditional surgical methods.

摘要

研究目的

根据Querleu-Morrow分类法,研究凯门鳄能量设备在A类根治性腹腔镜子宫切除术(RLH)中的临床性能,该手术联合双侧输卵管卵巢切除术(BSO)及对早期子宫内膜癌(EC)老年患者进行盆腔淋巴结评估,特别关注止血效果和安全性。

设计

单机构前瞻性观察性研究。

地点

意大利罗马圣心天主教大学综合医院IRCCS基金会妇科肿瘤科室。

患者

2021年9月至2023年8月纳入43例65岁以上、国际妇产科联盟(FIGO)分期为IA期或IB期的子宫内膜样EC患者。

干预措施

在老年患者的RLH联合BSO及盆腔淋巴结评估中使用凯门鳄能量设备。

测量指标

主要终点为手术时间,次要终点包括围手术期结局和术后并发症。

主要结果

结果显示中位手术时间为135分钟,未出现因凯门鳄设备导致的显著术中并发症。术后并发症极少,无严重并发症(4级或5级),中位住院时间为两天。

结论

该研究突出了凯门鳄设备在提高手术效率同时将老年患者风险降至最低方面的优势,表明其在肿瘤手术中改善资源分配和患者结局的潜力。本研究结果表明,在早期子宫内膜癌老年患者的手术中使用凯门鳄设备是可行的。与传统手术方法相比,未来需要进行前瞻性随机试验以确定其疗效。

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