Does completion of radical hysterectomy improve oncological outcomes of women with clinical early-stage cervical cancer and intraoperative detection of nodal involvement?: protocol for a systematic review and meta-analysis

Introduction 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 pa...

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Main Authors: Hui Xu, Qing Liu, Yu Xu, Yi Du, Ai Zheng, Cui Hu, Ya Jia, Qianwen Zhang, Yue-Dong He, Shuang-Shuang Cui, Yong Tian, Lin Ran, Fengmei Ke
Format: Article
Language:English
Published: BMJ Publishing Group 2022-07-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/7/e056848.full
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author Hui Xu
Qing Liu
Yu Xu
Yi Du
Ai Zheng
Cui Hu
Ya Jia
Qianwen Zhang
Yue-Dong He
Shuang-Shuang Cui
Yong Tian
Lin Ran
Fengmei Ke
author_facet Hui Xu
Qing Liu
Yu Xu
Yi Du
Ai Zheng
Cui Hu
Ya Jia
Qianwen Zhang
Yue-Dong He
Shuang-Shuang Cui
Yong Tian
Lin Ran
Fengmei Ke
author_sort Hui Xu
collection DOAJ
description Introduction 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?Methods and analysis 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 I2 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.Ethics and dissemination 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.PROSPERO registration number CRD42021273527.
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spelling doaj-art-68027365f3434d9fa8c79a5f037035de2025-01-31T08:50:11ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-056848Does completion of radical hysterectomy improve oncological outcomes of women with clinical early-stage cervical cancer and intraoperative detection of nodal involvement?: protocol for a systematic review and meta-analysisHui Xu0Qing Liu1Yu Xu2Yi Du3Ai Zheng4Cui Hu5Ya Jia6Qianwen Zhang7Yue-Dong He8Shuang-Shuang Cui9Yong Tian10Lin Ran11Fengmei Ke12Department of Obstetrics and Gynecology, Enshi Clinical College of Wuhan University, Enshi, Hubei, ChinaDepartment of Neurosurgery in Xiangya Hospital, Central South University, Changsha, Hunan, China1 National Clinical Research Center for Obstetrics and Gynecology, Department of Gynecological Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaDepartment of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, ChinaDepartment of Obstetrics and Gynecology, Sichuan University West China Second University Hospital, Chengdu, Sichuan, ChinaDepartment of Obstetrics and Gynaecology, Mianzhu Peoples Hospital, Mianzhu, ChinaDepartment of Obstetrics and Gynaecology, Sichuan University West China Second University Hospital, Chengdu, Sichuan, ChinaDepartment of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, ChinaDepartment of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, ChinaDepartment of Obstetrics and Gynecology, Jianshi Hospital of Chinese Medicine, JianShi, Hubei, ChinaDepartment of Obstetrics and Gynecology, Enshi Clinical College of Wuhan University, Enshi, Hubei, ChinaDepartment of Obstetrics and Gynecology, Enshi Clinical College of Wuhan University, Enshi, Hubei, ChinaDepartment of Obstetrics and Gynecology, Enshi Clinical College of Wuhan University, Enshi, Hubei, ChinaIntroduction 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?Methods and analysis 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 I2 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.Ethics and dissemination 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.PROSPERO registration number CRD42021273527.https://bmjopen.bmj.com/content/12/7/e056848.full
spellingShingle Hui Xu
Qing Liu
Yu Xu
Yi Du
Ai Zheng
Cui Hu
Ya Jia
Qianwen Zhang
Yue-Dong He
Shuang-Shuang Cui
Yong Tian
Lin Ran
Fengmei Ke
Does completion of radical hysterectomy improve oncological outcomes of women with clinical early-stage cervical cancer and intraoperative detection of nodal involvement?: protocol for a systematic review and meta-analysis
BMJ Open
title Does completion of radical hysterectomy improve oncological outcomes of women with clinical early-stage cervical cancer and intraoperative detection of nodal involvement?: protocol for a systematic review and meta-analysis
title_full Does completion of radical hysterectomy improve oncological outcomes of women with clinical early-stage cervical cancer and intraoperative detection of nodal involvement?: protocol for a systematic review and meta-analysis
title_fullStr Does completion of radical hysterectomy improve oncological outcomes of women with clinical early-stage cervical cancer and intraoperative detection of nodal involvement?: protocol for a systematic review and meta-analysis
title_full_unstemmed Does completion of radical hysterectomy improve oncological outcomes of women with clinical early-stage cervical cancer and intraoperative detection of nodal involvement?: protocol for a systematic review and meta-analysis
title_short Does completion of radical hysterectomy improve oncological outcomes of women with clinical early-stage cervical cancer and intraoperative detection of nodal involvement?: protocol for a systematic review and meta-analysis
title_sort does completion of radical hysterectomy improve oncological outcomes of women with clinical early stage cervical cancer and intraoperative detection of nodal involvement protocol for a systematic review and meta analysis
url https://bmjopen.bmj.com/content/12/7/e056848.full
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