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More info
You can access this
clinical trial
if you have
Cervical Cancer or Urinary Retention
and you are
-
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Procedure: BiClamp group
  • Procedure: water jet group

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT03020238. The sponsor of the trial is Peking Union Medical College Hospital and it is looking for 120 volunteers for the current phase.
Official trial title:
Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics: a Randomized Controlled Trial