Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer

Shanghai Gynecologic Oncology Group62 enrolled

Overview

The purpose of this study is to evaluate the feasibility of complete nerve-sparing type C1 radical hysterectomy in cervical cancer.

The primary objective of this study is to evaluate the rate of postvoid residual urine volume (PVR) \<50ml on postoperative day 4 in patients with stage IB1 and IIA1 cervix cancer underwent complete nerve-sparing type C1 radical hysterectomy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Squamous Cell Carcinoma Cervical Adenocarcinoma Malignant Neoplasm of Cervix Stage IB1 Stage IIA1 Cervical Cancer

Interventions

Nerve-Sparing Radical HysterectomyPROCEDURE

Type C1 NSRH Removal indwelling catheter on day 4 after surgery

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \>=18 years to \<= 70 years. * Women with histologically confirmed, primary adenocarcinoma or squamous cell carcinoma of the uterine cervix. * Stage IIA1, or IB1 disease. * Karnofsky performance status \>70. * Patients who comply with follow-up. * With written informed consent. Exclusion Criteria: * Age\>70 * History of lower urinary tract damage or surgery. * With abnormal urodynamic study results. * Karnofsky performance status \<70. * Patients who have uncontrolled psychological disorders. * Unwilling to or unable to comply with protocol. * Prior treatment with pelvic radiotherapy

Locations (1)

Fudan University Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Proportion of patients with fully pelvic nerve plexus preserved

Proportion of patients who had a postvoid residual urine volume (PVR) under 50ml at postoperative day 4

Time frame: up to 30 days

Proportion of patients removing indwelling catheter

Time frame: up to 30 days

Secondary Outcomes

The rate of 36-month local control

Time frame: up to 36 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.