J Gynecol Oncol.
2024 May;35(3):e23. 10.3802/jgo.2024.35.e23.
Impact of peritoneal vaginoplasty combined with radical hysterectomy on the quality of sexual life for patients with early-stage cervical cancer: trial protocol for a multi-center superiority 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, Tongji Hospital Affiliated to Tongji University, Shanghai, China
- 3Department of Obstetrics and Gynecology, Shanghai General Hospital of Shanghai Jiaotong University School of Medicine, Shanghai, China
- 4Department of Obstetrics and Gynecology, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
- 5Department of Gynecologic Oncology, The International Peace Maternity & Child Health Hospital (IPMCH) of China Welfare Institute (CWI), Shanghai, China
- 6Department of Obstetrics and Gynecology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
- KMID: 2564890
- DOI: http://doi.org/10.3802/jgo.2024.35.e23
Abstract
- Background
Radical hysterectomy (RH) is commonly used to treat early-stage cervical cancer in women of childbearing age and sexual dysfunction due to postoperative vaginal shortening is a major concern. The impact of intraoperative vaginoplasty on prognosis and quality of sexual life in patients with early-stage cervical cancer remains controversial and lacks high-level evidence. However, there are few reports on vaginoplasty after RH to lengthen vagina in patients. This prospective, multi-center, randomized controlled trial aims to explore the impact of peritoneal vaginoplasty with or without ovarian transposition after laparoscopic RH on sexual dysfunction in patients with early-stage cervical cancer.
Methods
Eligible patients will be randomly assigned (1:1) to receive peritoneal vaginoplasty or not. The primary evaluation indicators are female sexual function index (FSFI) and male sexual satisfaction scale. The secondary evaluation indicators include EORTC QLQ-CX24, 2-year overall survival (OS), 5-year OS, 2-year progression-free survival (PFS), 5-year PFS and surgery-related complications. The trial will enroll 368 patients from 6 hospitals in China over a 3-year period and follow up for 5 years. Trial Registration Chinese Clinical Trial Registry Identifier: ChiCTR2000040610 Synopsis It's a prospective, randomized controlled trial to explore the effect of peritoneal vaginoplasty with or without ovarian transposition following laparoscopic radical hysterectomy on sexual dysfunction in patients with cervical cancer. The trial will enroll 368 patients from 6 hospitals in China over a 3-year period and follow up for 5 years.
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