Bipolar Enbloc Versus Thulium-Yag Enbloc Resection of Bladder Tumors

NCT06119724 | Active Not Recruiting DMC

• 1 other identifier: Bipolar and Thulium-Yag Enbloc
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (5)

• Enbloc technique effectiveness in obtaining muscle in the speciment

  Assessed by presence of muscles in histopathological specimen.

  3 months

• Duration of cancer free survival post enbloc resection

  Duration of Cancer free survival post resection measured by weeks.

  1year

• Staging of bladder cancer post enbloc resection

  Clinical staging using bimanual examination under anesthesia.

  1year

• Presence of residual tumors post resection

  Assessed by visualization of any residual mass during second look cystoscopy

  3-6 months

• Blood loss

  Assessed by comparing between Hemoglobin level pre and post operative

  Immediate postoperative

Study Arms (2)

Bipolar enbloc resection of bladder tumors

ACTIVE COMPARATOR

Patients who have odd number will be in the first group which will be enrolled in bipolar enbloc group

Procedure: Bipolar enbloc resection of bladder tumor

Thulium enbloc resection of bladder tumors

ACTIVE COMPARATOR

patients who have even number will be in the second group which will be Thulium-Yag laser enbloc group

Procedure: Thulium laser enbloc resection of bladder tumor

Interventions

Bipolar enbloc resection of bladder tumor PROCEDURE

Enbloc retrival of bladder tumor entoto using cystoscopy using bipolar

Bipolar enbloc resection of bladder tumors

Thulium laser enbloc resection of bladder tumor PROCEDURE

Enbloc retrival of bladder tumor entoto using cystoscopy using thulium laser

Thulium enbloc resection of bladder tumors

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with NMIBC
• Bladder tumors\<4 cm in CT.
• Resectable bladder tumors.
• Age \<80 years.

You may not qualify if:

• Bladder tumours \> 4cm .
• Metastatic bladder tumors.
• Patients with carcinoma in situ CIS .
• Patients with coagulopathies.
• Domal bladder tumors.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia university hospital

Shibīn al Kawm, Menoufia, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of urology

Study Record Dates

• First Submitted: June 17, 2023
• First Posted: November 7, 2023
• Study Start: June 11, 2023
• Primary Completion: November 10, 2025
• Study Completion: December 29, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

EG (1)