NCT03020238

Brief Summary

Background: Radical hysterectomy is an important therapy for early cervical cancer. Disfunction of urinary dynamics is the most common postoperative adverse effects, which had negative impact on patients' quality of life. Nerve sparing radical hysterectomy (NSRH) could reserve inferior hypogastric plexus (IHP) innervating bladder, hence improving postoperative urinary dynamics. Furthermore impact of different energy instruments on urinary dynamic isn't clear. Objectives: This study is to compare urinary dynamics before and after NSRH, and to analyze the difference between BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen, Germany) and water jet (ERBEJET®2) about the effects of dissecting IHP. Study population: Cervical cancer of FIGO IB stage, among which 120 cases are enrolled to randomly allocated to BiClamp group or water jet group. Intervention: Patients accept NSRH which all will be accomplished by Professor Ming Wu. Methods: All surgical patients are accessed via urinary dynamics before and four months after NSRH. On the 14th day after surgeries, urinary catheter will be removed and residual urine volume (RUV) will be measured. For patients of RUV \> 100 ml, urinary catheter will be replaced. Primary study endpoint: the successful rate of removing urinary catheter on the 14th day after NSRH. Secondary study endpoint: urinary dynamics four months after NSRH.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

January 11, 2017

Last Update Submit

January 12, 2017

Conditions

Cervical CancerUrinary Retention

Outcome Measures

Primary Outcomes (1)

  • successful rate of removing urinary catheter

    successful rate (%) of removing urinary catheter assessed by residual urine volume less than 100 ml

    14th day after nerve-sparing radical hysterectomy

Secondary Outcomes (8)

  • urinary dynamics parameters determined by urodynamics apparatus: bladder capacity and sensation

    four months after nerve-sparing radical hysterectomy

  • urinary dynamics parameters determined by urodynamics apparatus: residual urine volume

    four months after nerve-sparing radical hysterectomy

  • urinary dynamics parameters determined by urodynamics apparatus: urine flow rate

    four months after nerve-sparing radical hysterectomy

  • urinary dynamics parameters determined by urodynamics apparatus: bladder pressure

    four months after nerve-sparing radical hysterectomy

  • urinary dynamics parameters determined by urodynamics apparatus: detrusor pressure

    four months after nerve-sparing radical hysterectomy

  • +3 more secondary outcomes

Study Arms (2)

BiClamp group

PLACEBO COMPARATOR

BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus

Procedure: BiClamp group

water jet group

ACTIVE COMPARATOR

water jet (ERBEJET®2, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus

Procedure: water jet group

Interventions

BiClamp groupPROCEDURE

electric energy

Also known as: BiClamp® forcep, ERBE Elektromedizin
BiClamp group
water jet groupPROCEDURE

water jet energy

Also known as: ERBEJET®2, ERBE Elektromedizin
water jet group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • FIGO stage IB
  • ASA score 0-2

You may not qualify if:

  • Radiotherapy or chemotherapy before surgeries
  • ASA score \> 2
  • With abnormal urinary dynamics before surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUrinary Retention

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUrination DisordersUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Wu Ming, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 13, 2017

Study Start

January 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2017

Last Updated

January 13, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

IPD will be shared with authorised researchers via online database.