Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder

Phase 3

• Conditions: Urinary Bladder Neoplasm
• Interventions: Procedure: Holmium versus Bipolar en bloc transurethral resection

• Registration Number: NCT04576286
• Lead Sponsor: Ain Shams University

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.

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

Study Timeline

• Study Start: 2020-07-24
• Study First Submitted: 2020-09-16
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-01
• Last Update Submitted: 2020-10-01
• Study First Posted: 2020-10-06
• Last Update Posted: 2020-10-06
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Holmium en bloc resection	Holmium versus Bipolar en bloc transurethral resection	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
bipolar en bloc resection	Holmium versus Bipolar en bloc transurethral resection	bipolar en bloc tumor resection of urinary bladder tumors

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
hematuria	postoperative complication up to 2 weeks	(Yes/No)
Operative time	intraoperative finding	calculation of operative time in minutes
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
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

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt