Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Cantonal Hospital of St. Gallen
Sponsor:
Information provided by (Responsible Party):
Daniel Stephan Engeler, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01446822
First received: October 3, 2011
Last updated: January 31, 2014
Last verified: January 2014
  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 Phase
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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • Successful resection of bladder tumor [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Degree of severity of the complications (perforation of the bladder, intraoperative bleeding, postoperative bleeding, others) according to the Clavien-classification


Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • prothrombine time <70%
  • age <18 years
  • patronized Patients
  • pregnancy
  • severe poor medical condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446822

Contacts
Contact: Tobias Gramann, MD 0041714941415 tobias.gramann@kssg.ch
Contact: Daniel S Engeler, MD 0041714941430 daniel.engeler@kssg.ch

Locations
Switzerland
Cantonal Hospital of St.Gallen Recruiting
St. Gallen, Switzerland, 9007
Contact: Tobias Gramann    0041714941415    tobias.gramann@kssg.ch   
Principal Investigator: Tobias Gramann, MD         
Sponsors and Collaborators
Daniel Stephan Engeler
Investigators
Study Chair: Daniel S Engeler, MD Cantonal Hospital St. Gallen
  More Information

No publications provided

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
Study First Received: October 3, 2011
Last Updated: January 31, 2014
Health Authority: Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on October 20, 2014