Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

Not Applicable

Completed

• Conditions: Neoplasm of Lateral Wall of Urinary Bladder
• Interventions: Device: Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius); Device: Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole)

• Registration Number: NCT01446822
• Lead Sponsor: Daniel Stephan Engeler

Brief 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?

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-03
• Study First Submitted QC: 2011-10-04
• Study First Posted: 2011-10-05
• Primary Completion: 2016-06
• Study Completion: 2016-09
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bipolar transurethral resection	Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius)	-
Monopolar transurethral resection	Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole)	-

Primary Outcome Measures

Name	Time	Method
Successful resection of bladder tumor	Intraoperative	Successful resection of the neoplasm without relevant stimulation of the obturator nerve and consecutive contraction of the ipsilateral adductor muscles

Secondary Outcome Measures

Name	Time	Method
Complications	3 months	Degree of severity of the complications (perforation of the bladder, intraoperative bleeding, postoperative bleeding, others) according to the Clavien-classification

Trial Locations

Locations (1)

Cantonal Hospital of St.Gallen; 🇨🇭 St. Gallen, Switzerland