NCT01446822

Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Daniel Stephan Engeler · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2011-10-01
• Primary completion: 2016-06-01
• Completion: 2016-09-01
• First posted: 2011-10-05
• Last updated: 2018-03-05

Locations

1 site across 1 country: Switzerland