Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

Study Overview
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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?

Official Title
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Transurethral Resection of Bladder Tumors Without Obturator Nerve Block or Relaxation: Extent of Adductor Muscle Contraction With Monopolar Versus Bipolar Resection Technique

Conditions
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Neoplasm of Lateral Wall of Urinary Bladder

Intervention / Treatment
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* Device: Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius)
* Device: Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bipolar transurethral resection<br> | Device: Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius)<br>* 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.<br>* Other names: Fresenius Natriumchlorid 9,0g/l (Fresenius Kabi AG, Homburg, Germany);|
| Active Comparator: Monopolar transurethral resection<br> | Device: Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole)<br>* 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.<br>* Other names: Purisole®SM (Fresenius Kabi AG, Homburg, Germany);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful resection of bladder tumor | Successful resection of the neoplasm without relevant stimulation of the obturator nerve and consecutive contraction of the ipsilateral adductor muscles | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Degree of severity of the complications (perforation of the bladder, intraoperative bleeding, postoperative bleeding, others) according to the Clavien-classification | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary bladder neoplasm, bipolar transurethral resection, monopolar transurethral resection, obturator nerve