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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Urinary Retention; Cervical Cancer

Treatments: Procedure: water jet group; Procedure: BiClamp group

Study type: Interventional

Funder types: Other

Identifiers

NCT03020238

PUMCH-OBGYN-2013

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

BiClamp group

Placebo Comparator group

Description:

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

Treatment:

Procedure: BiClamp group

water jet group

Active Comparator group

Description:

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

Treatment:

Procedure: water jet group