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Completed

NCT Number: NCT01446822

Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

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?

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Key information

Conditions

Neoplasm of Lateral Wall of Urinary Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cantonal Hospital of St.Gallen

Sankt Gallen, 9007, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius)

Device

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)

Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole)

Device

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Daniel Stephan Engeler

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Oct 5, 2011
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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