An interventional study of BiClamp group and water jet group in Cervical Cancer and Urinary Retention, sponsored by Peking Union Medical College Hospital. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2017-01-13.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
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.
235 studies on the registry are indexed under Urinary Retention; 39 are open to participants now.
This study's enrollment of 120 is above the median of 95 across 185 interventional studies indexed under Urinary Retention.
Browse Urinary Retention studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus
Procedure: BiClamp group
water jet (ERBEJET®2, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus
Procedure: water jet group
electric energy
Also known as: BiClamp® forcep, ERBE Elektromedizin
water jet energy
Also known as: ERBEJET®2, ERBE Elektromedizin
successful rate of removing urinary catheter
successful rate (%) of removing urinary catheter assessed by residual urine volume less than 100 ml
Time frame: 14th day after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: bladder capacity and sensation
bladder capacity and sensation in ml
Time frame: four months after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: residual urine volume
residual urine volume in ml
Time frame: four months after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: urine flow rate
urine flow rate in ml/s
Time frame: four months after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: bladder pressure
bladder pressure in cmH2O
Time frame: four months after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: detrusor pressure
detrusor pressure in cmH2O
Time frame: four months after nerve-sparing radical hysterectomy
urinary dynamics parameters determined by urodynamics apparatus: bladder compliance
bladder compliance in ml/cmH2O
Time frame: four months after nerve-sparing radical hysterectomy
survival outcomes: ovarall survival
overall survival in months
Time frame: two years after nerve-sparing radical hysterectomy
survival outcomes: progression-free survival
progression-free survival in months
Time frame: two years after nerve-sparing radical hysterectomy
No study locations are listed for this record.
Plan to share: Yes — IPD will be shared with authorised researchers via online database.
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital