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
1 other identifier
interventional
62
1 country
1
Brief Summary
The purpose of this study is to evaluate the feasibility of complete nerve-sparing type C1 radical hysterectomy in cervical cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 18, 2015
CompletedFirst Posted
Study publicly available on registry
September 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedOctober 14, 2016
July 1, 2016
1 year
September 18, 2015
October 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
up to 30 days
Proportion of patients removing indwelling catheter
up to 30 days
Secondary Outcomes (1)
The rate of 36-month local control
up to 36 months
Study Arms (1)
Nerve-Sparing Radical Hysterectomy (NSRH)
EXPERIMENTALType C1 Hysterectomy
Interventions
Type C1 NSRH Removal indwelling catheter on day 4 after surgery
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Gynecologic Oncology Grouplead
- Fudan Universitycollaborator
Study Sites (1)
Fudan University Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
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.
PMID: 29163840DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rongyu Zang, MD,PhD
Fudan University Shanghai Zhongshan Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2015
First Posted
September 29, 2015
Study Start
September 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
October 14, 2016
Record last verified: 2016-07