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Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01446822
First Posted: October 5, 2011
Last Update Posted: June 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniel Stephan Engeler, Cantonal Hospital of St. Gallen
  Purpose

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?


Condition Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Daniel Stephan Engeler, Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 44
Study Start Date: October 2011
Study Completion Date: September 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • PlasmaKinetic resectoscope
  • Gyrus PlasmaKinetic SuperPulse generator (Gyrus Medical Inc., Maple Grove, USA)
  • Fresenius Natriumchlorid 9,0g/l (Fresenius Kabi AG, Homburg, Germany)
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.
Other Names:
  • Resectoscope Model 27050 (Karl Storz GmbH & Co. KG, Tuttlingen, Germany)
  • Erbotom ICC 350 (Deltamed-ERBE AG,Winterthur, Switzerland)
  • Purisole®SM (Fresenius Kabi AG, Homburg, Germany)

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446822


Locations
Switzerland
Cantonal Hospital of St.Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Daniel Stephan Engeler
Investigators
Study Chair: Daniel S Engeler, MD Cantonal Hospital St. Gallen
  More Information

Responsible Party: Daniel Stephan Engeler, Leitender Arzt, Klinik für Urologie, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT01446822     History of Changes
Other Study ID Numbers: URO-OBT-01
First Submitted: October 3, 2011
First Posted: October 5, 2011
Last Update Posted: June 28, 2017
Last Verified: June 2017

Keywords provided by Daniel Stephan Engeler, Cantonal Hospital of St. Gallen:
urinary bladder neoplasm
bipolar transurethral resection
monopolar transurethral resection
obturator nerve

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases