Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors
Transurethral Resection of Bladder Tumors Without Obturator Nerve Block or Relaxation: Extent of Adductor Muscle Contraction With Monopolar Versus Bipolar Resection Technique
1 other identifier
interventional
44
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 3, 2011
CompletedFirst Posted
Study publicly available on registry
October 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedMarch 5, 2018
March 1, 2018
4.7 years
October 3, 2011
March 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Intraoperative
Secondary Outcomes (1)
Complications
3 months
Study Arms (2)
Bipolar transurethral resection
EXPERIMENTALMonopolar transurethral resection
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- neoplasms of the lateral wall of the urinary bladder (laterally to the corresponding ostium)
- operability given based on general medical condition
- informed consent
You may not qualify if:
- antiplatelet drugs stopped \<7days (except acetylsalicylate \<= 100mg p.o. qd)
- prothrombine time \<70%
- age \<18 years
- patronized Patients
- pregnancy
- severe poor medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cantonal Hospital of St.Gallen
Sankt Gallen, 9007, Switzerland
Related Publications (1)
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.
PMID: 29497859RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Daniel S Engeler, MD
Cantonal Hospital of St. Gallen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Leitender Arzt, Klinik für Urologie
Study Record Dates
First Submitted
October 3, 2011
First Posted
October 5, 2011
Study Start
October 1, 2011
Primary Completion
June 1, 2016
Study Completion
September 1, 2016
Last Updated
March 5, 2018
Record last verified: 2018-03