Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors
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?
|Neoplasm of Lateral Wall of Urinary Bladder||Device: Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius) Device: Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Transurethral Resection of Bladder Tumors Without Obturator Nerve Block or Relaxation: Extent of Adductor Muscle Contraction With Monopolar Versus Bipolar Resection Technique|
- Successful resection of bladder tumor [ Time Frame: Intraoperative ]Successful resection of the neoplasm without relevant stimulation of the obturator nerve and consecutive contraction of the ipsilateral adductor muscles
- Complications [ Time Frame: 3 months ]Degree of severity of the complications (perforation of the bladder, intraoperative bleeding, postoperative bleeding, others) according to the Clavien-classification
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
|Experimental: Bipolar transurethral resection||
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.
|Active Comparator: Monopolar transurethral resection||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446822
|Contact: Tobias Gramann, MDemail@example.com|
|Contact: Daniel S Engeler, MDfirstname.lastname@example.org|
|Cantonal Hospital of St.Gallen||Recruiting|
|St. Gallen, Switzerland, 9007|
|Contact: Tobias Gramann 0041714941415 email@example.com|
|Principal Investigator: Tobias Gramann, MD|
|Study Chair:||Daniel S Engeler, MD||Cantonal Hospital St. Gallen|