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Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics

Primary Purpose

Cervical Cancer, Urinary Retention

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

BiClamp group

water jet group

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

FIGO stage IB
ASA score 0-2

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

BiClamp group

water jet group

Arm Description

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

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

Outcomes

Primary Outcome Measures

successful rate of removing urinary catheter

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

Secondary Outcome Measures

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

bladder capacity and sensation in ml

urinary dynamics parameters determined by urodynamics apparatus: residual urine volume

residual urine volume in ml

urinary dynamics parameters determined by urodynamics apparatus: urine flow rate

urine flow rate in ml/s

urinary dynamics parameters determined by urodynamics apparatus: bladder pressure

bladder pressure in cmH2O

urinary dynamics parameters determined by urodynamics apparatus: detrusor pressure

detrusor pressure in cmH2O

urinary dynamics parameters determined by urodynamics apparatus: bladder compliance

bladder compliance in ml/cmH2O

survival outcomes: ovarall survival

overall survival in months

survival outcomes: progression-free survival

progression-free survival in months

Full Information

NCT ID

NCT03020238

First Posted

January 11, 2017

Last Updated

January 12, 2017

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03020238

Brief Title

Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics

Official Title

Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer, Urinary Retention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BiClamp group

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

water jet group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

BiClamp group

Other Intervention Name(s)

BiClamp® forcep, ERBE Elektromedizin

Intervention Description

electric energy

Intervention Type

Procedure

Intervention Name(s)

water jet group

Other Intervention Name(s)

ERBEJET®2, ERBE Elektromedizin

Intervention Description

water jet energy

Primary Outcome Measure Information:

Title

successful rate of removing urinary catheter

Description

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

Time Frame

14th day after nerve-sparing radical hysterectomy

Secondary Outcome Measure Information:

Title

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

Description

bladder capacity and sensation in ml

Time Frame