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Completed

NCT Number: NCT03020238

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

BiClamp group

Procedure

electric energy

Other names: BiClamp® forcep, ERBE Elektromedizin

water jet group

Procedure

water jet energy

Other names: ERBEJET®2, ERBE Elektromedizin

Primary outcomes

  1. successful rate of removing urinary catheter

    Time frame: 14th day after nerve-sparing radical hysterectomy

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

Secondary outcomes

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

    Time frame: four months after nerve-sparing radical hysterectomy

    bladder capacity and sensation in ml

  2. urinary dynamics parameters determined by urodynamics apparatus: residual urine volume

    Time frame: four months after nerve-sparing radical hysterectomy

    residual urine volume in ml

  3. urinary dynamics parameters determined by urodynamics apparatus: urine flow rate

    Time frame: four months after nerve-sparing radical hysterectomy

    urine flow rate in ml/s

  4. urinary dynamics parameters determined by urodynamics apparatus: bladder pressure

    Time frame: four months after nerve-sparing radical hysterectomy

    bladder pressure in cmH2O

  5. urinary dynamics parameters determined by urodynamics apparatus: detrusor pressure

    Time frame: four months after nerve-sparing radical hysterectomy

    detrusor pressure in cmH2O

  6. urinary dynamics parameters determined by urodynamics apparatus: bladder compliance

    Time frame: four months after nerve-sparing radical hysterectomy

    bladder compliance in ml/cmH2O

  7. survival outcomes: ovarall survival

    Time frame: two years after nerve-sparing radical hysterectomy

    overall survival in months

  8. survival outcomes: progression-free survival

    Time frame: two years after nerve-sparing radical hysterectomy

    progression-free survival in months

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jan 13, 2017
Registry last updated
Jan 13, 2017

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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