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Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

Primary Purpose

Neoplasm of Lateral Wall of Urinary Bladder

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius)
Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole)
Sponsored by
Daniel Stephan Engeler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm of Lateral Wall of Urinary Bladder focused on measuring urinary bladder neoplasm, bipolar transurethral resection, monopolar transurethral resection, obturator nerve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cantonal Hospital of St.Gallen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bipolar transurethral resection

Monopolar transurethral resection

Arm Description

Outcomes

Primary Outcome Measures

Successful resection of bladder tumor
Successful resection of the neoplasm without relevant stimulation of the obturator nerve and consecutive contraction of the ipsilateral adductor muscles

Secondary Outcome Measures

Complications
Degree of severity of the complications (perforation of the bladder, intraoperative bleeding, postoperative bleeding, others) according to the Clavien-classification

Full Information

First Posted
October 3, 2011
Last Updated
March 2, 2018
Sponsor
Daniel Stephan Engeler
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1. Study Identification

Unique Protocol Identification Number
NCT01446822
Brief Title
Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors
Official Title
Transurethral Resection of Bladder Tumors Without Obturator Nerve Block or Relaxation: Extent of Adductor Muscle Contraction With Monopolar Versus Bipolar Resection Technique
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Stephan Engeler

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm of Lateral Wall of Urinary Bladder
Keywords
urinary bladder neoplasm, bipolar transurethral resection, monopolar transurethral resection, obturator nerve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bipolar transurethral resection
Arm Type
Experimental
Arm Title
Monopolar transurethral resection
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius)
Other Intervention Name(s)
PlasmaKinetic resectoscope, Gyrus PlasmaKinetic SuperPulse generator (Gyrus Medical Inc., Maple Grove, USA), Fresenius Natriumchlorid 9,0g/l (Fresenius Kabi AG, Homburg, Germany)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole)
Other Intervention Name(s)
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)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Successful resection of bladder tumor
Description
Successful resection of the neoplasm without relevant stimulation of the obturator nerve and consecutive contraction of the ipsilateral adductor muscles
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Complications
Description
Degree of severity of the complications (perforation of the bladder, intraoperative bleeding, postoperative bleeding, others) according to the Clavien-classification
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel S Engeler, MD
Organizational Affiliation
Cantonal Hospital St. Gallen
Official's Role
Study Chair
Facility Information:
Facility Name
Cantonal Hospital of St.Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29497859
Citation
Gramann T, Schwab C, Zumstein V, Betschart P, Meier M, Schmid HP, Engeler DS. Transurethral resection of bladder cancer on the lateral bladder wall without obturator nerve block: extent of adductor spasms using the monopolar versus bipolar technique-a prospective randomised study. World J Urol. 2018 Jul;36(7):1085-1091. doi: 10.1007/s00345-018-2248-0. Epub 2018 Mar 1.
Results Reference
result
Links:
URL
http://rdcu.be/H7MJ
Description
Full text view of publication in World Journal of Urology

Learn more about this trial

Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

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