Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-09-30

Brief Summary

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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?

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Detailed Description

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Conditions

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Neoplasm of Lateral Wall of Urinary Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bipolar transurethral resection

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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.

Monopolar transurethral resection

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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PlasmaKinetic resectoscope Gyrus PlasmaKinetic SuperPulse generator (Gyrus Medical Inc., Maple Grove, USA) Fresenius Natriumchlorid 9,0g/l (Fresenius Kabi AG, Homburg, Germany) Resectoscope Model 27050 (Karl Storz GmbH & Co. KG, Tuttlingen, Germany) Erbotom ICC 350 (Deltamed-ERBE AG,Winterthur, Switzerland) Purisole®SM (Fresenius Kabi AG, Homburg, Germany)

Eligibility Criteria

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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 (except acetylsalicylate \<= 100mg p.o. qd)
* prothrombine time \<70%
* age \<18 years
* patronized Patients
* pregnancy
* severe poor medical condition

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No