A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer

NCT01886508 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2013-07-22

No results posted yet for this study

Summary

The investigators designed this multicentre randomized study to investigate the clinical benefits of nerve-spring radical hysterectomy for cervical cancer. Patients with FIGO stage Ia2, Ib1, IIa1 and FIGO stage Ib2, IIa2 after neoadjuvant chemotherapy are randomized to either nerve-spring radical hysterectomy or radical hysterectomy. The primary endpoint are urodynamic outcome including maximum flow rate, residual volume, maximum vesical compliace, cystomctric capacity at first desire, and maximum cystomctric capacity. A total 240 patients (120 per treatment arm) are planned to accrue for this study within 7 years.

Conditions

Interventions

PROCEDURE

Nerve-spring radical hysterectomy

Nerve-spring radical hysterectomy that is reserve some pelvic autonomic nerves during radical hysterectomy. Reserve hypogastric nerve trunk during dissecting cardinal ligament. Reserve pelvic splanchnic nerve trunk during exsecting uterosacral ligament. Reserve bladder nerve of pelvic plexus during dissecting vesicouterine ligament.

PROCEDURE

radical hysterectomy

Radical hysterectomy is Piver III hysterectomy and Q-M classification Type C1 hysterectomy.

Sponsors & Collaborators

  • Tumor Hospital of Xin Jiang Medical University,China

    collaborator UNKNOWN
  • Gui Yang Maternal and Child Health Hospital,China

    collaborator UNKNOWN
  • The 152nd Hospital of chinese People's Liberation Army

    collaborator UNKNOWN
  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-12-31
Completion
2020-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01886508 on ClinicalTrials.gov