背景:宫颈癌是第四种最常见的癌症,也是女性癌症死亡的第四大原因,早期宫颈癌女性的标准治疗建议是根治性子宫切除术伴盆腔淋巴结清扫术,然而,近年来发表的文章得出结论,腹腔镜手术对宫颈癌的治疗效果不如开腹手术。因此,我们选择了一种新的手术入路;腹腔镜宫颈癌手术在开放状态下与传统的开放宫颈癌手术相比,我们希望患者仍能有良好的肿瘤预后和生存结果。本试验将探讨腹腔镜宫颈癌手术在开腹状态下治疗早期宫颈癌的有效性。
方法:这将是一个开放标签,2武装,随机化,比较早期宫颈癌患者基于开放状态的腹腔镜根治性子宫切除术与开腹根治性子宫切除术的III期单中心试验。总共740名参与者将以1:1的比例随机分配到2个治疗组。临床,实验室,超声,放射学数据将在基线时收集,然后在基线和1周进行的研究评估和程序,6周,三个月,术后3个月开始随访,之后每3个月持续1次随访,持续前2年,每6个月随访1次,直至第4.5年.主要目标是4.5年的无病生存率。次要目标包括治疗相关的发病率,成本和成本效益,复发的模式,生活质量,盆底功能,和总体生存率。
结论:这项前瞻性试验旨在显示腹腔镜宫颈癌手术在开放状态下与经腹根治性子宫切除术治疗早期宫颈癌患者的2期方案的等效性。
背景:ChiCTR2300075118。2023年8月25日注册。
BACKGROUND: Cervical cancer is the fourth most frequently diagnosed cancer and the fourth leading cause of cancer death in women, The standard treatment recommendation for women with early cervical cancer is radical hysterectomy with pelvic lymph node dissection, however, articles published in recent years have concluded that the treatment outcome of laparoscopic surgery for cervical cancer is inferior to that of open surgery. Thus, we choose a surgically new approach; the laparoscopic cervical cancer surgery in the open state is compared with the traditional open cervical cancer surgery, and we hope that patients can still have a good tumor outcome and survival outcome. This trial will investigate the effectiveness of laparoscopic cervical cancer surgery in the open-state treatment of early-stage cervical cancer.
METHODS: This will be an open-label, 2-armed, randomized, phase-III single-center trial of comparing laparoscopic radical hysterectomy based on open state with abdominal radical hysterectomy in patients with early-stage cervical cancer. A total of 740 participants will be randomly assigned into 2 treatment arms in a 1:1 ratio. Clinical, laboratory, ultrasound, and radiology data will be collected at baseline, and then at the study assessments and procedures performed at baseline and 1 week, 6 weeks, and 3 months, and follow-up visits begin at 3 months following surgery and continue every 3 months thereafter for the first 2 years and every 6 months until year 4.5. The primary aim is the rate of disease-free survival at 4.5 years. The secondary aims include treatment-related morbidity, costs and cost-effectiveness, patterns of recurrence, quality of life, pelvic floor function, and overall survival.
CONCLUSIONS: This prospective trial aims to show the equivalence of the laparoscopic cervical cancer surgery in the open state versus the transabdominal radical hysterectomy approach for patients with early-stage cervical cancer following a 2-phase protocol.
BACKGROUND: ChiCTR2300075118. Registered on August 25, 2023.