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

Urinary Bladder Neoplasm Clinical Trial

Official title:

Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04576286
• Other study ID #: FMASU R32/2020
• Status: Recruiting
• Phase: Phase 3
• Start date: July 24, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: October 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Bladder Neoplasm
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Holmium 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participant with Conversion to the TURBT	conversion from the enbloc way of resection to the standard trans-urethral resection of bladder tumors	intraoperative finding
Secondary	Operative time	calculation of operative time in minutes	intraoperative finding
Secondary	Presence of detrusor muscle in resected sample	presence of muscle layer in the pathological specimen (Yes/No)	one day after surgery during pathological evaluation
Secondary	Resected specimen's edge	tumor free margin (Yes/No)	one day after surgery during pathological evaluation
Secondary	intraoperative complication: bladder perforation	(Yes/No) bladder perforation	intraoperative
Secondary	Incidence of obturator reflex	(Yes/No) energy induced obturator reflex	intraoperative
Secondary	hematuria	(Yes/No)	postoperative complication up to 2 weeks
Secondary	Post-operative catheterization time in hours	time till catheter removal in days	postoperative complication up to 2 weeks
Secondary	Postoperative irrigation time in hours	hours for the need of postoperative irrigation	postoperative in hours maximum 1 day
Secondary	Recurrence rate of tumors according to time interval	recurrence of tumor in the follow up cystoscopy	1 year
Secondary	Recurrence rate of tumors according to tumor location	recurrence of tumor in the follow up cystoscopy in the same site or in different site	1 year