Department of Obstetrics and Gynecology, Mianzhu City People's Hospital, Mianzhu, Sichuan, China
Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China.
BMJ Open. 2022 Jul 29;12(7):e056848. doi: 10.1136/bmjopen-2021-056848.
The management of women with clinical early-stage cervical cancer and lymph node involvement detected intraoperatively is heterogeneous and controversial. This paper presents the protocol of a systematic review and meta-analysis regarding the management of this specific population of patients. This proposed study aims to answer the question: does completion of radical hysterectomy improve the oncological outcomes of women with clinical early-stage cervical cancer and intraoperatively detected nodal involvement?
This protocol is drafted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines, and the proposed study will be conducted in accordance with the standard guidelines of 'Preferred Reporting Items for Systematic Reviews and Meta-Analyses' and 'Meta-analysis of Observational Studies in Epidemiology reporting guideline'. Comprehensive literature searches will be performed in PubMed, Embase, Scopus, and Web of Science. The screening of the eligible studies, the extraction of data of interest, and the quality assessment of the included studies will all be independently performed by different members of our team. The primary outcome of this proposed study will be comparing the risk of recurrence or death from cervical cancer and the risk of all-cause death in patients with two different treatments (completion of radical hysterectomy or abandonment of radical hysterectomy); the secondary outcome of this proposed study will be comparing the risk of the grade 3/4 toxicities associated with the two types of management. Given the clinical heterogeneity among the included studies, data on outcomes will be pooled by random-effects models. Heterogeneity will be evaluated using the statistic. The risk of bias for the included studies will be evaluated using the Newcastle-Ottawa Scale or the Cochrane collaboration's tool. The grade of evidence will be evaluated by two independent members of our team using the Grading of Recommendations, Assessment, Development and Evaluations approach.
Ethical approval is not required because there will no primary data collected. The findings of this proposed study will be published in an international peer-reviewed journal.
CRD42021273527.
对于术中检测到有淋巴结受累的临床早期宫颈癌患者的处理方法存在多样性和争议。本文提出了一项关于此类特殊患者群体管理的系统评价和荟萃分析的方案。本研究旨在回答以下问题：对于临床早期宫颈癌且术中检测到淋巴结受累的患者，完成根治性子宫切除术是否能改善其肿瘤学结局？
本方案是根据系统评价和荟萃分析首选报告项目指南制定的，拟进行的研究将遵循“系统评价和荟萃分析首选报告项目”和“观察性研究荟萃分析的流行病学报告指南”的标准指南进行。将在 PubMed、Embase、Scopus 和 Web of Science 中进行全面的文献检索。合格研究的筛选、感兴趣数据的提取以及纳入研究的质量评估将由我们团队的不同成员独立进行。本研究的主要结局是比较两种不同治疗方法（完成根治性子宫切除术或放弃根治性子宫切除术）的患者宫颈癌复发或死亡风险和全因死亡风险；本研究的次要结局是比较两种管理方式相关的 3/4 级毒性风险。由于纳入研究的临床异质性，将采用随机效应模型汇总结局数据。使用 I² 统计量评估异质性。使用纽卡斯尔-渥太华量表或 Cochrane 协作工具评估纳入研究的偏倚风险。我们团队的两名独立成员将使用推荐评估、制定与评估分级法评估证据等级。
由于不会收集原始数据，因此不需要伦理批准。本研究的结果将发表在国际同行评议期刊上。
PROSPERO 注册号：CRD42021273527。
