Transurethral Resection of Bladder Tumors Without Obturator Nerve Block or Relaxation: Extent of Adductor Muscle Contraction With Monopolar Versus Bipolar Resection Technique
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Successful resection of bladder tumor
Study Overview
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?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Bipolar transurethral resection
Intervention: Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius) (Device)
Monopolar transurethral resection
Intervention: Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole) (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Complications(3 months)
Investigators
Daniel Stephan Engeler
Leitender Arzt, Klinik für Urologie
Cantonal Hospital of St. Gallen