子宫内膜癌分期中的剖腹手术与腹腔镜手术比较
2026年6月6日 更新者：AM Abdelbary、Assiut University
Perioperative Outcomes of Surgical Staging in Patients With Early-stage Endometrial Carcinoma: Comparison Between Laparoscopy and Laparotomy in a Low-resource Setting
子宫内膜癌是全球最常见的妇科恶性肿瘤之一。手术分期是管理的基石，传统上通过开腹手术进行。然而，微创手术，特别是腹腔镜手术，已成为一种有效的替代方案，在减少术后并发症方面具有潜在优势。
本研究旨在比较在资源匮乏地区腹腔镜与开腹（开腹）手术分期治疗子宫内膜癌患者的结果。主要结果是比较腹腔镜与开腹盆腔淋巴结清扫术的手术时间。次要结果包括术中并发症、术中失血量、住院时间、恢复参数和肿瘤学结果。
考虑到资源匮乏地区资源有限且手术专业水平存在差异，本研究旨在评估腹腔镜与开腹手术相比的可行性、安全性和有效性。研究结果可能有助于在类似的医疗环境中指导临床决策并优化手术方法。
研究概览
详细说明
子宫内膜癌是发达国家最常见的妇科恶性肿瘤，其发病率在全球范围内持续上升。大多数患者因异常子宫出血等症状就诊时处于疾病早期，这有助于早期诊断和治疗。手术治疗仍然是治疗的基石，通常包括全子宫切除术加双侧输卵管卵巢切除术，根据患者的风险因素和疾病分期决定是否进行淋巴结清扫。<\/p>
盆腔淋巴结清扫在准确分期、预后分层以及指导辅助治疗决策中起着重要作用。传统上，手术分期通过开腹手术进行，这能够为淋巴结清扫提供充分的暴露。然而，开腹手术与显著的围术期并发症相关，包括出血量增加、术后疼痛、住院时间延长以及伤口并发症发生率升高。<\/p>
微创手术作为开腹手术的替代方案，已在妇科肿瘤学中越来越多地被采用。腹腔镜方法具有多种优势，包括改善解剖结构的可视化、减少术中出血量、加快恢复速度和缩短住院时间。多项研究已评估了腹腔镜手术分期在子宫内膜癌中的可行性和安全性。除了传统的经腹腔途径，腹腔镜腹膜外淋巴结清扫术作为一种避免进入腹腔的技术已经出现，在特定患者中可能具有优势，特别是肥胖或广泛腹腔内粘连的患者。然而，腹膜外淋巴结清扫技术要求高，需要良好的空间定向能力。<\/p>
微创手术分期的肿瘤学安全性已在随机LAP2试验中得到证实，该试验显示腹腔镜和开腹手术分期的复发率和生存结果相似，同时腹腔镜提供了更好的围术期结果。<\/p>
分子病理学的最新进展引入了基于癌症基因组图谱（TCGA）基因组分析的子宫内膜癌分子分类系统。该分类将肿瘤分为四个主要分子亚组：POLE超突变型、微卫星不稳定或错配修复缺陷型、拷贝数低型（p53野生型）和拷贝数高型（p53异常型）。分子分类提供了重要的预后信息，已被纳入现代风险分层系统，以指导子宫内膜癌的辅助治疗和手术决策。<\/p>
因此，本研究假设在资源有限的环境下，与开腹盆腔淋巴结清扫相比，腹腔镜盆腔淋巴结清扫术能为子宫内膜癌患者提供更好的围术期结局，同时保持相当的肿瘤学安全性。<\/p>
研究类型
介入性
注册 (估计的)
48
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Alaa El-Din Mahmoud Ismail, professor
- 电话号码：+201001106048
- 邮箱：alaaismail@aun.edu.eg
研究联系人备份
- 姓名：Hisham El-Sayed Abou-Taleb, professor
- 电话号码：+201003332139
学习地点
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Asyut、埃及
- 招聘中
- Assiut University, Assiut,
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接触：
- Alaa El-Din Mahmoud Ismail, professor
- 电话号码：+201001106048
- 邮箱：alaaismail@aun.edu.eg
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接触：
- Abdulrahman Muhammad Rageh, lecturer
- 电话号码：+201005056259
- 邮箱：Abdulrahmanrageh@med.aun.edu.eg
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 经阴道超声/内膜活检或诊刮检查后，由组织学证实的子宫内膜癌。
- 根据ESGO/ESTRO/ESP 2021年7版指南中子宫内膜癌风险分层确定需要行盆腔淋巴结清扫的候选患者。
- 计划的手术分期包括：全子宫切除术、双侧输卵管卵巢切除术及盆腔淋巴结清扫术。
- 良好的体力状态：ECOG 0, 1, 2。
提供书面知情同意并同意参与研究的患者。
b. 排除标准：
- 严重的心肺疾病（例如不稳定型心绞痛、重度慢性阻塞性肺疾病）。
- 腹腔镜的绝对禁忌症。
- Ⅲ期和Ⅳ期子宫内膜癌。
- 既往接受过盆腔放疗的患者。
- 既往接受过淋巴结清扫术的患者。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Laparoscopic surgical staging
surgical staging by laparoscopy
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surgical staging by laparoscopy
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其他：Open surgical staging (laparotomy)
surgical staging by open surgery
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surgical staging through open surgery
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Early postoperative recovery assessed by time to ambulation (hours).
大体时间：From the end of surgery until the patient achieves independent ambulation or ambulation with minimal assistance, assessed during the first 24 postoperative hours.
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From the end of surgery until the patient achieves independent ambulation or ambulation with minimal assistance, assessed during the first 24 postoperative hours.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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短期肿瘤学结果
大体时间：随访一年
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One-year disease-free survival (DFS), defined as the time from surgery to first documented recurrence (local, regional, or distant) or death from any cause.
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随访一年
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术后恢复质量
大体时间：在术后12小时、24小时、48小时以及出院时（术后最多5天）。
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术后恢复质量通过恢复质量问卷-15（QoR-15问卷）评估 0-150 130-150：恢复极佳 122-129：恢复良好 90-121：恢复一般 <90：恢复差/显著术后障碍
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在术后12小时、24小时、48小时以及出院时（术后最多5天）。
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Comparison of hospital stay duration between laparoscopic and open surgical staging
大体时间：From the day of surgery through hospital discharge, assessed up to 7 days postoperatively.
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From the day of surgery through hospital discharge, assessed up to 7 days postoperatively.
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comparsion between same day discgarge between laparoscopic and open surgical staging
大体时间：Day 0 (day of surgery)
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Day 0 (day of surgery)
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Pelvic lymph node yield (number of nodes)
大体时间：At final histopathological examination (within 2 weeks postoperatively)
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Comparison of the total number of pelvic lymph nodes retrieved between laparoscopic and open surgical staging.
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At final histopathological examination (within 2 weeks postoperatively)
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Comparison of estimated blood loss during surgery between laparoscopic and open surgical staging.
大体时间：During surgery (intraoperative period)
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During surgery (intraoperative period)
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Comparison of intraoperative complications between laparoscopic and open surgical staging.
大体时间：During surgery
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During surgery
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Postoperative complications (Clavien-Dindo classification, Grades I-V)
大体时间：Within 30 days after surgery
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Comparison of the incidence and severity of postoperative complications between laparoscopic and open surgical staging.
Complications will be graded according to the Clavien-Dindo classification, where Grade I represents minor deviation from normal postoperative course and Grade V represents death.
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Within 30 days after surgery
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comparsion of health-related quality of life assessed using the EQ-5D-5L questionnaire between open and laparoscopic surgical staging
大体时间：baseline (preoperative), 6 weeks, and 12 weeks postoperatively.
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baseline (preoperative), 6 weeks, and 12 weeks postoperatively.
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hospital-based cost comparison between both surgical approaches
大体时间：From surgery until hospital discharge, assessed up to 30 days postoperatively.
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Hospital-based costs will include operating room time cost, surgical instruments and energy devices, hospital stay cost, and costs related to the management of postoperative complications occurring within 30 days after surgery.
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From surgery until hospital discharge, assessed up to 30 days postoperatively.
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Discrepancy between preoperative curettage pathology and final histopathology
大体时间：From preoperative endometrial sampling through final postoperative histopathological assessment, up to 30 days after surgery.
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Comparison of histological type, tumor grade, and disease characteristics between preoperative endometrial sampling pathology and the final postoperative histopathological diagnosis.
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From preoperative endometrial sampling through final postoperative histopathological assessment, up to 30 days after surgery.
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Conversion Rate
大体时间：guring surgery
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Rate and causes of conversion from laparoscopy to open surgery in the laparoscopic arm.
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guring surgery
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Delay in initiation of adjuvant therapy
大体时间：Defined as the interval between date of surgery and initiation of adjuvant chemotherapy and/or radiotherapy. Delayed initiation will be considered when adjuvant treatment is started more than 6 weeks after surgery.
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Defined as the interval between date of surgery and initiation of adjuvant chemotherapy and/or radiotherapy. Delayed initiation will be considered when adjuvant treatment is started more than 6 weeks after surgery.
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Readmission within 6 weeks after surgery.
大体时间：within 6 weeks postoperative
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within 6 weeks postoperative
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Total postoperative analgesic consumption during hospital stay.
大体时间："From arrival at the recovery room until hospital discharge (up to 72 hours postoperatively)"
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"From arrival at the recovery room until hospital discharge (up to 72 hours postoperatively)"
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Time to bowel function recovery
大体时间：From the end of surgery until first passage of flatus and stool, assessed up to 7 days postoperatively.
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From the end of surgery until first passage of flatus and stool, assessed up to 7 days postoperatively.
|
|
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Time to oral intake
大体时间：From the end of surgery until first tolerated oral intake, assessed up to 72 hours postoperatively.
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From the end of surgery until first tolerated oral intake, assessed up to 72 hours postoperatively.
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Postoperative pain score using Visual Analogue Scale (VAS)
大体时间：Time Frame: 6, 12, 24, and 48 hours postoperatively, and at hospital discharge (up to 7 days postoperatively).
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Time Frame: 6, 12, 24, and 48 hours postoperatively, and at hospital discharge (up to 7 days postoperatively).
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009 Nov 10;27(32):5331-6. doi: 10.1200/JCO.2009.22.3248. Epub 2009 Oct 5.
- Abu-Rustum NR. Sentinel lymph node mapping for endometrial cancer: a modern approach to surgical staging. J Natl Compr Canc Netw. 2014 Feb;12(2):288-97. doi: 10.6004/jnccn.2014.0026.
- Concin N, Matias-Guiu X, Vergote I, Cibula D, Mirza MR, Marnitz S, Ledermann J, Bosse T, Chargari C, Fagotti A, Fotopoulou C, Gonzalez Martin A, Lax S, Lorusso D, Marth C, Morice P, Nout RA, O'Donnell D, Querleu D, Raspollini MR, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Colombo N, Planchamp F, Creutzberg CL. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma. Int J Gynecol Cancer. 2021 Jan;31(1):12-39. doi: 10.1136/ijgc-2020-002230. Epub 2020 Dec 18.
- Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.
- Weiss ME, Piacentine LB. Psychometric properties of the Readiness for Hospital Discharge Scale. J Nurs Meas. 2006 Winter;14(3):163-80. doi: 10.1891/jnm-v14i3a002.
- Concin N, Matias-Guiu X, Cibula D, Colombo N, Creutzberg CL, Ledermann J, Mirza MR, Vergote I, Abu-Rustum NR, Bosse T, Chargari C, Espenel S, Fagotti A, Fotopoulou C, Gatius S, Gonzalez-Martin A, Lax S, Levy B, Lorusso D, Macchia G, Marth C, Morice P, Oaknin A, Raspollini MR, Schwameis R, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Planchamp F, Nout RA. ESGO-ESTRO-ESP guidelines for the management of patients with endometrial carcinoma: update 2025. Lancet Oncol. 2025 Aug;26(8):e423-e435. doi: 10.1016/S1470-2045(25)00167-6.
- Jaiswal A, Huang KG. "Energy devices in gynecological laparoscopy - Archaic to modern era". Gynecol Minim Invasive Ther. 2017 Oct-Dec;6(4):147-151. doi: 10.1016/j.gmit.2017.08.002. Epub 2017 Sep 1.
- Torok P, Krasznai Z, Molnar S, Lampe R, Jakab A. Preoperative assessment of endometrial cancer. Transl Cancer Res. 2020 Dec;9(12):7746-7758. doi: 10.21037/tcr-20-2068.
- Kong TW, Lee KM, Cheong JY, Kim WY, Chang SJ, Yoo SC, Yoon JH, Chang KH, Ryu HS. Comparison of laparoscopic versus conventional open surgical staging procedure for endometrial cancer. J Gynecol Oncol. 2010 Jun;21(2):106-11. doi: 10.3802/jgo.2010.21.2.106. Epub 2010 Jun 30.
- Bretova P, Ndukwe MI, Laco J, Vosmikova H, Reslova T, Pohankova D, Balcarova K, Haviger J, Havigerova JM, Sirak I. Preoperative risk stratification in endometrial cancer using ESGO/ESTRO/ESP 2021 guidelines: accuracy with and without molecular classification. BMC Cancer. 2025 Aug 11;25(1):1302. doi: 10.1186/s12885-025-14741-5.
- Imai K, Hirooka-Nakama J, Hotta Y, Shigeta H. A Review of Laparoscopic Para-aortic Lymphadenectomy for Early-stage Endometrial Cancer: Extraperitoneal Approach May Have the Advantage over Intraperitoneal Approach. Gynecol Minim Invasive Ther. 2023 Oct 31;13(1):10-18. doi: 10.4103/gmit.gmit_25_23. eCollection 2024 Jan-Mar.
- Galaal K, Donkers H, Bryant A, Lopes AD. Laparoscopy versus laparotomy for the management of early stage endometrial cancer. Cochrane Database Syst Rev. 2018 Oct 31;10(10):CD006655. doi: 10.1002/14651858.CD006655.pub3.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月2日
初级完成 (估计的)
2028年4月1日
研究完成 (估计的)
2028年10月1日
研究注册日期
首次提交
2026年4月9日
首先提交符合 QC 标准的
2026年4月16日
首次发布 (实际的)
2026年4月23日
研究记录更新
最后更新发布 (实际的)
2026年6月10日
上次提交的符合 QC 标准的更新
2026年6月6日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- EC-STAGE-LL-2026
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