J Gynecol Oncol.
2024 May;35(3):e81. 10.3802/jgo.2024.35.e81.
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
- Affiliations
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- 1Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China
- 2Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, China
- 3Department of Gynecology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
- 4Department of Gynecology, First Maternity and Infant Hospital Affiliated to Tongji University, Shanghai, China
- 5Department of Gynecology, Ganzhou People’s Hospital, Ganzhou, China
- 6Department of Gynecology, The Affiliated Ganzhou Hospital of Nanchang University, Ganzhou, China
- 7Department of Obstetrics and Gynecology, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
- KMID: 2564903
- DOI: http://doi.org/10.3802/jgo.2024.35.e81
Abstract
- Background
Several 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.
Methods
A 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 Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2000035668
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