Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer

A Simplified Approach of Complete Nerve-sparing Type C1 Radical Hysterectomy for Cervical Cancer, a Phase II Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02562729

Enrollment

Registered

2015-09-29

Start date

2015-09-30

Completion date

2016-09-30

Last updated

2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Cervical cancer; Nerve-sparing hysterectomy; simplified

Brief summary

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

Detailed 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.

Interventions

PROCEDURENerve-Sparing Radical Hysterectomy

Type C1 NSRH Removal indwelling catheter on day 4 after surgery

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients with fully pelvic nerve plexus preserved	up to 30 days	Proportion of patients who had a postvoid residual urine volume (PVR) under 50ml at postoperative day 4
Proportion of patients removing indwelling catheter	up to 30 days	—

Secondary

Measure	Time frame
The rate of 36-month local control	up to 36 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026