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.

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.

[Application of video endoscopic inguinal lymphadenectomy in radical vulvectomy for carcinoma].

OBJECTIVE: To evaluate the feasibility and safety of applying video endoscopic inguinal lymphadenectomy via hypogastric subcutaneous approach (VEIL-H) in the treatment of vulvar carcinoma. METHODS: From September 2009 to December 2012, 15 patients with vulvar carcinoma underwent VEIL-H plus radical vulvectomy at many participating hospitals. RESULTS: All were treated surgically. Two of them underwent laparoscopic pelvic lymphadenectomy (LPL) upon the positive results of parotid operations with frozen section. The mean operative duration of VEIL-H (bilateral groin) were (80.8 ± 2.9) minutes. The mean total volume of blood loss in VEIL was (5.5 ± 0.4) ml, the mean drainage duration (6 ± 2) days and the average postoperative hospitalization (11 ± 4) days. The mean follow-up period was 13.0 months. One patient suffered local recurrence at Month 2 postoperation. CONCLUSION: VEIL-H is both feasible and safe in inguinal lymphadenectomy.