Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer

NCT ID: NCT02562729

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nerve-Sparing Radical Hysterectomy (NSRH)

Type C1 Hysterectomy

Group Type EXPERIMENTAL

Nerve-Sparing Radical Hysterectomy

Intervention Type PROCEDURE

Type C1 NSRH Removal indwelling catheter on day 4 after surgery

Interventions

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Nerve-Sparing Radical Hysterectomy

Type C1 NSRH Removal indwelling catheter on day 4 after surgery

Intervention Type PROCEDURE

Other Intervention Names

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Fully Pelvic-Nerve Plexus Preserved

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role collaborator

Shanghai Gynecologic Oncology Group

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rongyu Zang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University Shanghai Zhongshan Hospital

Locations

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Fudan University Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Zhang Y, Shi T, Yin S, Ma S, Shi D, Guan J, Xiang L, Liu Y, Ren Y, Tan D, Zang R. An improved nerve-sparing radical hysterectomy technique for cervical cancer using the paravesico-vaginal space as a new surgical landmark. Oncotarget. 2017 Jul 5;8(52):90413-90420. doi: 10.18632/oncotarget.19011. eCollection 2017 Oct 27.

Reference Type DERIVED
PMID: 29163840 (View on PubMed)

Other Identifiers

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zsfdu-obgyn-003

Identifier Type: -

Identifier Source: org_study_id

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