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Bipolar Enbloc Versus Thulium-Yag Enbloc Resection of Bladder Tumors

NCT ID: NCT06119724

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-11

Study Completion Date

2025-12-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bipolar enbloc resection of bladder tumors

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

Group Type ACTIVE_COMPARATOR

Bipolar enbloc resection of bladder tumor

Intervention Type PROCEDURE

Enbloc retrival of bladder tumor entoto using cystoscopy using bipolar

Thulium enbloc resection of bladder tumors

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

Group Type ACTIVE_COMPARATOR

Thulium laser enbloc resection of bladder tumor

Intervention Type PROCEDURE

Enbloc retrival of bladder tumor entoto using cystoscopy using thulium laser

Interventions

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Bipolar enbloc resection of bladder tumor

Enbloc retrival of bladder tumor entoto using cystoscopy using bipolar

Intervention Type PROCEDURE

Thulium laser enbloc resection of bladder tumor

Enbloc retrival of bladder tumor entoto using cystoscopy using thulium laser

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Bladder tumours \> 4cm .
2. Metastatic bladder tumors.
3. Patients with carcinoma in situ CIS .
4. Patients with coagulopathies.
5. Domal bladder tumors.
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Kamal Omar

Associate professor of urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Menoufia university hospital

Shibīn al Kawm, Menoufia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Bipolar and Thulium-Yag Enbloc

Identifier Type: -

Identifier Source: org_study_id