Urinary Bladder Neoplasm
Conditions
Keywords
urinary bladder tumors, en bloc resection, holmium laser, bipolar, TURBT
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.
Interventions
PROCEDUREHolmium versus Bipolar en bloc transurethral resection
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients will be blinded to the type of intervention as well as the data collector and the statistician.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of participant with Conversion to the TURBT | intraoperative finding | conversion from the enbloc way of resection to the standard trans-urethral resection of bladder tumors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of detrusor muscle in resected sample | one day after surgery during pathological evaluation | presence of muscle layer in the pathological specimen (Yes/No) |
| Resected specimen's edge | one day after surgery during pathological evaluation | tumor free margin (Yes/No) |
| intraoperative complication: bladder perforation | intraoperative | (Yes/No) bladder perforation |
| Incidence of obturator reflex | intraoperative | (Yes/No) energy induced obturator reflex |
| Operative time | intraoperative finding | calculation of operative time in minutes |
| Post-operative catheterization time in hours | postoperative complication up to 2 weeks | time till catheter removal in days |
| Postoperative irrigation time in hours | postoperative in hours maximum 1 day | hours for the need of postoperative irrigation |
| Recurrence rate of tumors according to time interval | 1 year | recurrence of tumor in the follow up cystoscopy |
| Recurrence rate of tumors according to tumor location | 1 year | recurrence of tumor in the follow up cystoscopy in the same site or in different site |
| hematuria | postoperative complication up to 2 weeks | (Yes/No) |
Countries
Egypt
Outcome results
None listed