Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

Daniel Stephan Engeler44 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasm of Lateral Wall of Urinary Bladder

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Intraoperative

Secondary Outcomes

Complications

Degree of severity of the complications (perforation of the bladder, intraoperative bleeding, postoperative bleeding, others) according to the Clavien-classification

Time frame: 3 months