Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors
Conditions
Neoplasm of Lateral Wall of Urinary Bladder
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
urinary bladder neoplasm, bipolar transurethral resection, monopolar transurethral resection, obturator nerve
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius) Type: Device
Name: Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole) Type: Device
Overall Status
Recruiting
Summary
This is a single-center, prospective, randomized, controlled trial comparing two established transurethral electrical resection methods of urinary bladder tumors regarding their risk of stimulating the obturator nerve.

One of the major safety issues with transurethral resection is bladder perforation as a consequence of obturator nerve stimulation followed by muscle contraction of. This is mostly a risk of resection of lateral bladder wall tumors near the course of the obturator nerve. It has been advocated that bipolar may be superior to monopolar resection, based on its different electrical properties. This is an important safety aspect for the patient.

Main study question: In patients with lateral wall urinary bladder tumors, is bipolar superior to monopolar transurethral electroresection regarding risk of stimulation of the obturator nerve without preoperative nerve block?
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- neoplasms of the lateral wall of the urinary bladder (laterally to the corresponding ostium)

- operability given based on general medical condition

- informed consent

Exclusion Criteria:

- antiplatelet drugs stopped <7days

- prothrombine time <70%

- age <18 years

- patronized Patients

- pregnancy

- severe poor medical condition
Location
Cantonal Hospital of St.Gallen
St. Gallen, Switzerland
Status: Recruiting
Contact: Tobias Gramann - 0041714941415 - tobias.gramann@kssg.ch
Start Date
October 2011
Completion Date
March 2016
Sponsors
Daniel Stephan Engeler
Source
Cantonal Hospital of St. Gallen
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page