Neoplasm of Lateral Wall of Urinary Bladder Clinical Trial
Official title:
Transurethral Resection of Bladder Tumors Without Obturator Nerve Block or Relaxation: Extent of Adductor Muscle Contraction With Monopolar Versus Bipolar Resection Technique
| Verified date | March 2018 |
| Source | Cantonal Hospital of St. Gallen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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?
| Status | Completed |
| Enrollment | 44 |
| Est. completion date | September 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Cantonal Hospital of St.Gallen | St. Gallen |
| Lead Sponsor | Collaborator |
|---|---|
| Daniel Stephan Engeler |
Switzerland,
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 p
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Complications | Degree of severity of the complications (perforation of the bladder, intraoperative bleeding, postoperative bleeding, others) according to the Clavien-classification | 3 months |