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Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

NCT01446822 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-03-05

No results posted yet for this study

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?

Conditions

  • Neoplasm of Lateral Wall of Urinary Bladder

Interventions

DEVICE

Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius)

Lateral wall urinary bladder tumors are resected transurethrally without obturator nerve block or relaxation under general anesthesia. If resection not possible because of adductor muscle contraction, patients undergo relaxation.

DEVICE

Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole)

Lateral wall urinary bladder tumors are resected transurethrally without obturator nerve block or relaxation under general anesthesia. If resection is not possible because of adductor muscle contraction, patients are treated by bipolar resection. If this is still not possible, they undergo relaxation.

Sponsors & Collaborators

  • Daniel Stephan Engeler

    lead OTHER

Principal Investigators

  • Daniel S Engeler, MD · Cantonal Hospital St. Gallen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2016-06-30
Completion
2016-09-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01446822 on ClinicalTrials.gov