En bloc resection of bladder tumors (ERBT) may improve staging quality and perioperative morbidity and influence tumour recurrence
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
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. Intervention: all procedures will be done by an expert surgeon who performed over 50 cases of en bloc urinary bladder tumor resection with each energy source. In group A, Holmium en bloc resection procedure will be done under either general or spinal anesthesia, using a Holmium laser device (Cyber Ho, Quanta device, Milano, Italy). We will use a 30-40-watt power, 1-2 joules and 20-30 MHz frequency for Group A and bipolar en bloc resection for Group B. A 550 nm flexible laser fiber will be used in group A and a bipolar resection loop for group B.
Ain Shams University Hospitals
Cairo, Egypt
number of participant with Conversion to the TURBT
conversion from the enbloc way of resection to the standard trans-urethral resection of bladder tumors
Time frame: intraoperative finding
Operative time
calculation of operative time in minutes
Time frame: intraoperative finding
Presence of detrusor muscle in resected sample
presence of muscle layer in the pathological specimen (Yes/No)
Time frame: one day after surgery during pathological evaluation
Resected specimen's edge
tumor free margin (Yes/No)
Time frame: one day after surgery during pathological evaluation
intraoperative complication: bladder perforation
(Yes/No) bladder perforation
Time frame: intraoperative
Incidence of obturator reflex
(Yes/No) energy induced obturator reflex
Time frame: intraoperative
hematuria
(Yes/No)
Time frame: postoperative complication up to 2 weeks
Post-operative catheterization time in hours
time till catheter removal in days
Time frame: postoperative complication up to 2 weeks
Postoperative irrigation time in hours
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hours for the need of postoperative irrigation
Time frame: postoperative in hours maximum 1 day
Recurrence rate of tumors according to time interval
recurrence of tumor in the follow up cystoscopy
Time frame: 1 year
Recurrence rate of tumors according to tumor location
recurrence of tumor in the follow up cystoscopy in the same site or in different site
Time frame: 1 year