Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IVTreatmentActive18 and overOtherURO-OBT-01
NCT01446822

Trial Description

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?

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
  • prothrombine time <70%
  • age <18 years
  • patronized Patients
  • pregnancy
  • severe poor medical condition

Trial Contact Information

Trial Lead Organizations/Sponsors

Daniel Stephan Engeler

    Daniel S Engeler, MD, Study Chair
    Tobias Gramann, MD
    Ph: 0041714941415
    Email: tobias.gramann@kssg.ch

    Trial Sites

    Switzerland

    St. Gallen

    Kantonsspital - St. Gallen

    Tobias Gramann
    Ph: 0041714941415
    Email: tobias.gramann@kssg.ch

    Tobias Gramann, MD
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01446822
    ClinicalTrials.gov processed this data on April 09, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.