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Clinical Trials/NCT01446822
NCT01446822
Completed
Not Applicable

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

Daniel Stephan Engeler1 site in 1 country44 target enrollmentOctober 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neoplasm of Lateral Wall of Urinary Bladder
Sponsor
Daniel Stephan Engeler
Enrollment
44
Locations
1
Primary Endpoint
Successful resection of bladder tumor
Status
Completed
Last Updated
8 years ago

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?

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
September 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Daniel Stephan Engeler
Responsible Party
Sponsor Investigator
Principal Investigator

Daniel Stephan Engeler

Leitender Arzt, Klinik für Urologie

Cantonal Hospital of St. Gallen

Eligibility Criteria

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

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)

Study Sites (1)

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