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NCT Number: NCT04576286

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

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

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Key information

Conditions

Urinary Bladder Neoplasm Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ain Shams University Hospitals

Cairo, 11361, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Holmium versus Bipolar en bloc transurethral resection

Procedure

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.

Primary outcomes

  1. number of participant with Conversion to the TURBT

    Time frame: intraoperative finding

    conversion from the enbloc way of resection to the standard trans-urethral resection of bladder tumors

Secondary outcomes

  1. Operative time

    Time frame: intraoperative finding

    calculation of operative time in minutes

  2. Presence of detrusor muscle in resected sample

    Time frame: one day after surgery during pathological evaluation

    presence of muscle layer in the pathological specimen (Yes/No)

  3. Resected specimen's edge

    Time frame: one day after surgery during pathological evaluation

    tumor free margin (Yes/No)

  4. intraoperative complication: bladder perforation

    Time frame: intraoperative

    (Yes/No) bladder perforation

  5. Incidence of obturator reflex

    Time frame: intraoperative

    (Yes/No) energy induced obturator reflex

  6. hematuria

    Time frame: postoperative complication up to 2 weeks

    (Yes/No)

  7. Post-operative catheterization time in hours

    Time frame: postoperative complication up to 2 weeks

    time till catheter removal in days

  8. Postoperative irrigation time in hours

    Time frame: postoperative in hours maximum 1 day

    hours for the need of postoperative irrigation

  9. Recurrence rate of tumors according to time interval

    Time frame: 1 year

    recurrence of tumor in the follow up cystoscopy

  10. Recurrence rate of tumors according to tumor location

    Time frame: 1 year

    recurrence of tumor in the follow up cystoscopy in the same site or in different site

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2020
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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