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
- Author:
Shimin YANG
1
;
Yan DING
;
Huaifang LI
;
Sufang WU
;
Weiwei FENG
;
Yudong WANG
;
Xipeng WANG
;
Keqin HUA
Author Information
- Publication Type:Clinical Trial Protocol
- From:Journal of Gynecologic Oncology 2024;35(3):e23-
- CountryRepublic of Korea
- Language:English
-
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 RegistrationChinese Clinical Trial Registry Identifier: ChiCTR2000040610SynopsisIt'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.
