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Active, Not Recruiting

NCT Number: NCT06119724

Bipolar Enbloc Versus Thulium-Yag Enbloc Resection of Bladder Tumors

Prospective controlled study randomized comparing bipolar enbloc versus thulium enbloc for bladder tumours

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia university hospital

Shibīn al Kawm, Menoufia, Egypt

About this study

Bladder cancer is the ninth most prevalent cancer worldwide and the 2nd most common urologic cancer in the last two decades after cancer prostate .

Most bladder cancers attributed to exposure to environmental and occupational chemicals, the largest of which by far is tobacco smoke. Greater tobacco smoke and occupational exposure in men may help in the explanation of the 4-fold gender difference in bladder cancer incidence .

Approximately 75-85% of patients with bladder cancer present with disease confined to the mucosa or submucosa , which is referred to as nonmuscle invasive bladder cancer (NMIBC).

Transurethral resection of bladder tumor (TURBT) is still considered the gold standard treatment for primary nonmuscle invasive bladder cancer.

There are many drawbacks for conventional TURBT procedure such as such as the deficiency of the bladder detrusor muscle In the specimen

, the obturator jerk, thermal damage to surrounding tissues, and the technique of( incise and scatter). These drawbacks may lead to difficulty in performing an accurate pathological evaluation of fragment tissue and increase the risk of recurrence.

Laser therapy for bladder cancer was first reported in Germany in the 1970s and was approved to clinical use in the USA in 1984.

Modern laser technology has led to new alternatives to conventional transurethral resection of bladder tumor (TURBT) due to its efficacy and good control of bleeding. With the introduction of en-bloc resection of urinary bladder tumors, Laser come back into focus. The two most commonly used lasers at present are thulium and holmium Laser.

In 2018 PA Geavlete, declared that the enbloc bipolar resection of bladder tumors using mushroom loop provide the advantages of superior surgical safety, decreased perioperative morbidity and faster postoperative recovery, when compared to the standard monopolar TURBT but showed no superiority in oncological outcome.

Who can participate

Healthy volunteers accepted: No

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

  • Inclusion criteria:
  • Patients with NMIBC
  • Bladder tumors<4 cm in CT.
  • Resectable bladder tumors.
  • Age <80 years.
  • Exclusion criteria :
  • Bladder tumours > 4cm .
  • Metastatic bladder tumors.
  • Patients with carcinoma in situ CIS .
  • Patients with coagulopathies.
  • Domal bladder tumors.

Treatment and study plan

Bipolar enbloc resection of bladder tumor

Procedure

Enbloc retrival of bladder tumor entoto using cystoscopy using bipolar

Thulium laser enbloc resection of bladder tumor

Procedure

Enbloc retrival of bladder tumor entoto using cystoscopy using thulium laser

Primary outcomes

  1. Enbloc technique effectiveness in obtaining muscle in the speciment

    Time frame: 3 months

    Assessed by presence of muscles in histopathological specimen.

  2. Duration of cancer free survival post enbloc resection

    Time frame: 1year

    Duration of Cancer free survival post resection measured by weeks.

  3. Staging of bladder cancer post enbloc resection

    Time frame: 1year

    Clinical staging using bimanual examination under anesthesia.

  4. Presence of residual tumors post resection

    Time frame: 3-6 months

    Assessed by visualization of any residual mass during second look cystoscopy

  5. Blood loss

    Time frame: Immediate postoperative

    Assessed by comparing between Hemoglobin level pre and post operative

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Bipolar Enbloc Versus Thulium-Yag Enbloc Resection Of Bladder Tumors: A Randomized Controlled Trial

Acronym: TURBT-Enbloc

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2023
Registry last updated
Nov 29, 2024

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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