Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer

Shanghai Gynecologic Oncology Group

Status and phase: Completed; Phase 2

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

Treatments: Procedure: Nerve-Sparing Radical Hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02562729

zsfdu-obgyn-003

Details and patient eligibility

About

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

Full description

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.

Enrollment: 62 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Nerve-Sparing Radical Hysterectomy (NSRH)

Experimental group

Description:

Type C1 Hysterectomy

Treatment:

Procedure: Nerve-Sparing Radical Hysterectomy