Evidence map›Paper›PMID 38522951›Full record

ArticleJournal of gynecologic oncology2024

Intraoperative frozen section pathology of vaginal margin in radical hysterectomy on the prognosis and quality of life for patients with IB2-IIA2 cervical cancer: study protocol for a multicenter randomized controlled trial.

Yu Liu, Weijuan Xin, Ping Wang, Mei Ji, Xiaoqing Guo, Yunyan Ouyang, Dong Zhao, Keqin Hua

Open access · diamondAbstract readClinical Trial Protocol
In one paragraph

Article in Journal of gynecologic oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 1 country.

Yu Liu *Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.ORCID 0000-0002-1235-9470
Weijuan Xin *Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.ORCID 0000-0001-8375-8076
Ping WangDepartment of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, China.ORCID 0000-0003-2429-5918
Mei JiDepartment of Gynecology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.ORCID 0000-0002-7049-1525
Xiaoqing GuoDepartment of Gynecology, First Maternity and Infant Hospital Affiliated to Tongji University, Shanghai, China.ORCID 0000-0002-2493-5156
Yunyan OuyangDepartment of Gynecology, Ganzhou People's Hospital, Ganzhou, China.ORCID 0009-0008-2474-895X
Dong ZhaoDepartment of Obstetrics and Gynecology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.ORCID 0000-0002-2118-2910
Keqin HuaDepartment of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China. huakeqinjiaoshou@163.com.ORCID 0000-0001-5359-8841
Obstetrics and Gynecology Hospital of Fudan University · CNFirst Affiliated Hospital of Zhengzhou University · CNGanzhou People's Hospital · CNShanghai First Maternity and Infant Hospital · CNShanghai Ninth People's Hospital · CNSichuan University · CN

Funding

Clinical Research Plan of SHDC SHDC2020CR1045B
6 · The paper itself

Abstract

backgroundSeveral risk factors have been identified that compromise the treatment outcome in patients with early-to-mid-stage cervical cancer (CC) who are primarily treated with radical surgery. However, there is no report on the impact of intraoperative frozen pathology examination of vaginal margins on the prognosis of patients with CC. This study aimed to conduct a randomized controlled trial (RCT) to determine whether selective vaginal resection can reduce the incidence of operative complications and the risk of postoperative radiotherapy. The impact of the length of the vagina removed in radical hysterectomy (RH) on prognosis and quality of life (QoL) for IB2-IIA2 CC patients will be investigated.

methodsA multicenter, non-inferiority, RCT at 7 institutions in China is designed to investigate the effect of intraoperative frozen pathology exam of vaginal margin in RH on the survival outcomes for patients with IB2-IIA2 CC. Eligible patients aged 18-70 years will be randomly assigned online by one-to-one random allocation to receive intraoperative frozen pathology exam of vaginal margin or not. If frozen pathology indicates positive margin, continue resection of 1 centimeter of vaginal tissue until negative margin is achieved. The primary end point is 2-year disease-free survival (DFS). Adverse events (AEs) caused by further vagina resection, 5-year DFS, 2-year overall survival (OS), 5-year OS and AEs caused by radiotherapy and QoL are secondary end points. A total of 310 patients will be enrolled from 7 tertiary hospitals in China within 3-year period and followed up for 5 years.

trial registrationChinese Clinical Trial Registry Identifier: ChiCTR2000035668.

Indexed as

Frozen SectionsHysterectomyMargins of ExcisionQuality of LifeUterine Cervical NeoplasmsAdolescentAdultAgedChinaDisease-Free SurvivalEquivalence Trials as TopicFemaleHumansMiddle AgedMulticenter Studies as TopicNeoplasm StagingBrachytherapyCervical CancerRadiotherapySurgical MarginUterine Cervical Neoplasms

Identifiers

PMID38522951
PMCPMC11107279
OpenAlexW4392813865

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.