Clinical trial NCT04576286: Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder
Official title: Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Bladder Neoplasm
Keywords: urinary bladder tumors
en bloc resection
holmium laser
bipolar
TURBT
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After obtaining informed consent, patients will be randomized with a 1:1 ratio using sealed envelopes that will be prepared by the department's ethical committee into 2 groups, group 1 represent the Holmium en bloc resection procedure while group 2 represents bipolar en bloc resection. Patients will be blinded to the type of intervention as well as the data collector and the statistician.
Primary purpose: TREATMENT

Brief summary: En bloc resection of bladder tumors (ERBT) may improve staging quality and perioperative morbidity and influence tumour recurrence

Detailed description: Modern laser technology has led to new alternatives to conventional TURBT (cTURBT). The advocates of ERBT have three goals: to improve resection quality, lower perioperative complication rates, and decrease recurrence rates at resection sites. The present study is the first to compare the results of laser and electric en bloc resection of bladder cancer with respect to the aforementioned goals.

the investigators aim to compare the clinical outcome in the form of safety and efficacy between Holmium and bipolar transurethral en bloc resection of urinary bladder tumors.

Eligibility criteria: Inclusion Criteria:

* Adult patients of both sexes presented with urinary bladder tumor aiming for complete resection as diagnosed by Ultrasound with or without CT prior histopathological assessment.

Exclusion Criteria:

* Patients with signs of extravesical tumor extension where complete resection will not beneficial or unable to proceed to complete resection due to huge tumor burden either huge single tumor more than 5 cm or multiple tumors that are not candidate for complete resection.

Primary outcomes:
measure: number of participant with Conversion to the TURBT
timeFrame: intraoperative finding
Secondary outcomes:
measure: Operative time
timeFrame: intraoperative finding
measure: Presence of detrusor muscle in resected sample
timeFrame: one day after surgery during pathological evaluation
measure: Resected specimen's edge
timeFrame: one day after surgery during pathological evaluation
measure: intraoperative complication: bladder perforation
timeFrame: intraoperative
measure: Incidence of obturator reflex
timeFrame: intraoperative
measure: hematuria
timeFrame: postoperative complication up to 2 weeks
measure: Post-operative catheterization time in hours
timeFrame: postoperative complication up to 2 weeks
measure: Postoperative irrigation time in hours
timeFrame: postoperative in hours maximum 1 day
measure: Recurrence rate of tumors according to time interval
timeFrame: 1 year
measure: Recurrence rate of tumors according to tumor location
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
References: