Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

March 2, 2018 updated by: Daniel Stephan Engeler

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • St. Gallen, Switzerland, 9007
        • Cantonal Hospital of St.Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniel Stephan Engeler

Investigators

  • Study Chair: Daniel S Engeler, MD, Cantonal Hospital St. Gallen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

October 3, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (ESTIMATE)

October 5, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URO-OBT-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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