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Completed

NCT Number: NCT02562729

Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer

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

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Key information

Conditions

Cervical Squamous Cell Carcinoma Cervical Adenocarcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Malignant Neoplasm of Cervix Stage IB1 Neoplasms Neoplasms by Site Stage IIA1 Cervical Cancer Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nerve-Sparing Radical Hysterectomy

Procedure

Type C1 NSRH Removal indwelling catheter on day 4 after surgery

Other names: Fully Pelvic-Nerve Plexus Preserved

Primary outcomes

  1. Proportion of patients with fully pelvic nerve plexus preserved

    Time frame: up to 30 days

    Proportion of patients who had a postvoid residual urine volume (PVR) under 50ml at postoperative day 4

  2. Proportion of patients removing indwelling catheter

    Time frame: up to 30 days

Secondary outcomes

  1. The rate of 36-month local control

    Time frame: up to 36 months

Sponsors and collaborators

Lead sponsor

Shanghai Gynecologic Oncology Group

Other Gov

Collaborators

  • Fudan University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 29, 2015
Registry last updated
Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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