Minimally Invasive Surgery Versus Open Radical Hysterectomy in Presumably Early Stage Cervical Cancer: a Retrospective Multicenter Non-inferiority Study Comparing Overall and Progression-free Survival.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- OS
研究概览
简要总结
The goal of this retrospective observational study with prospective follow-up is to compare the safety and treatment outcomes of radical laparoscopic hysterectomy (removal of the uterus with cervix) versus abdominal (open) hysterectomy performed after the publication of the LACC trial in women with early-stage cervical cancer.
Eligible participants will include adult, legally competent women diagnosed with early-stage cervical cancer (FIGO stages IB1-IIA1, excluding FIGO IB3) with negative sentinel lymph node biopsy (SNB) confirmed by ultrastaging.
The main questions it aims to answer are:
Is there a difference in overall survival (OS) and progression-free survival (PFS) between laparoscopic and abdominal radical hysterectomy? Are postoperative complication rates and recurrence patterns comparable between the two surgical approaches?
Researchers will compare outcomes in patients undergoing radical laparoscopic hysterectomy versus abdominal hysterectomy to assess differences in survival, complications, and recurrence.
Participants will:
Have undergone radical hysterectomy (type B or C per Querleu-Morrow classification), preceded optionally by conization, with the use of uterine manipulators and absence of vaginal cuff protection explicitly excluded; Have had SNB as part of surgical staging; Be followed every 6 months for 5 years; Undergo clinical gynecologic examination and transvaginal and/or transabdominal ultrasound during follow-up; Undergo additional imaging (CT and/or pelvic MRI) in case of symptoms suggestive of recurrence.
All participants will follow standard post-treatment surveillance. No additional interventions beyond routine follow-up will be performed. Data on OS, PFS, complications (within 30 and 60 days postoperatively, classified by Clavien-Dindo), duration of surgery, recurrence site, and demographic characteristics will be collected.
详细描述
Scientific Description This is a retrospective observational study with prospective follow-up designed to evaluate the long-term oncologic safety and perioperative outcomes of radical laparoscopic hysterectomy compared to abdominal (open) radical hysterectomy in women with early-stage cervical cancer. The study specifically addresses surgical management practices adopted after the publication of the Laparoscopic Approach to Cervical Cancer (LACC) trial, which reported inferior oncologic outcomes associated with minimally invasive surgery (MIS) for radical hysterectomy.
The primary objective of this study is to compare overall survival (OS) and progression-free survival (PFS) between the two surgical approaches. Secondary objectives include assessment of short-term surgical morbidity, recurrence patterns, and demographic and clinical factors potentially associated with adverse outcomes.
Study Population Eligible participants will be adult (≥18 years), legally competent women diagnosed with early-stage cervical cancer, defined as FIGO 2018 stages IB1 to IIA1, excluding IB3 tumors. All patients must have negative sentinel lymph node biopsy (SNB) results confirmed by ultrastaging.
To ensure homogeneity and minimize confounding associated with surgical technique, strict intraoperative criteria will be applied:
Use of a uterine manipulator is not permitted; A protective vaginal cuff closure maneuver (e.g., by suture, clamp, or stapler) must be performed to prevent tumor spillage during colpotomy; SNB may be performed as a first step, followed by radical hysterectomy classified as type B or C according to the Querleu-Morrow classification; Preoperative conization is allowed but not mandatory.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing radical hysterectomy type B or C according to the Querleu-Morrow classification for early-stage cervical cancer (FIGO stages IB1-IIA1, excluding FIGO IB3 between November 2018 and August 2025 Not using manipulator during surgery Vaginal cuff protective maneuver during surgery Conization before surgery (optional) SNB as a first stage of treatment (optional)
排除标准
- •Women undergoing surgery for advanced stage cervical cancer (FIGO >IIA1) or FIGO IB3 Metastasis detected in sentinel node biopsy (confirmed in ultrastaging) ECOG>2 Not willing to participate in the study Not willing to undergo CT-scans or gynecological examinations
结局指标
主要结局
OS
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival
次要结局
- Complications(From enrollment to the 30 and 60 days postoperatively)
- PFS(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
- Recurrence(Through study completion, an average of 6 months)
研究者
Krzysztof Nowosielski
Prof.
Medical University of Silesia