Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT06820502
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-11
First Post:
2025-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OUTCOMES of SIMULTANEOUS TRANSURETHRAL PROSTATE and BLADDER TUMOR RESECTION VERSUS TRANSURETHRAL BLADDER TUMOR RESECTION in BLADDER TUMOR with BLADDER PROSTATE HYPERPLASIA
Sponsor:
Allama Iqbal Medical College
Organization:
Study Overview
Official Title:
OUTCOMES of SIMULTANEOUS TRANSURETHRAL PROSTATE and BLADDER TUMOR RESECTION VERSUS TRANSURETHRAL BLADDER TUMOR RESECTION in BLADDER TUMOR with BLADDER PROSTATE HYPERPLASIA
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The rationale of my study is that studies have shown that between 50% and 70% of patients treated with trans-urethral bladder tumor resection (TURBT) alone for NMIBC have recurrence with stage and grade progression in 10% to 15% and because of this theoretical danger of tumor cell implantation, many urologists avoid simultaneous trans-urethral prostate resection (TURP) and TURBT due to fear of implantation of tumor cells in the denuded areas of the resected prostate and prefer to perform a separate procedure for each pathological condition. However, others observed no deleterious effects of simultaneous TURBT and TURP. This unsettled controversy that has spanned almost 4 decades. This study will delineate guidelines for outcome of these procedures in terms of better prognosis for patients.
OBJECTIVE:
The objective of the study is to compare the outcome of simultaneous trans-urethral bladder tumor and prostate resection versus trans-urethral bladder tumor resection alone in bladder tumor with prostate hyperplasia in terms of in terms of recurrence of bladder tumor SUBJECTS AND METHODS Study Design: Randomized controlled trial Settings: Department of Urology, Jinnah Hospital and Allama Iqbal Medical College, Lahore.
Study Population: Patients who will undergo TURP and TURBT at Jinnah Hospital, Lahore will be study population.
Duration of study: 3 months after approval of synopsis. Sampling Technique: Non-Probability / consecutive Sampling Sample Size: Sample size calculated with 80 % power of study and 5 % level of significance Assumed recurrence rate of simultaneous trans-urethral bladder tumor resection with prostate resection (Group A) = 53.6% Assumed recurrence rate of trans-urethral bladder tumor resection alone (Group B) = 86.9% Required sample size of total of 60 patients (30 patients in each group)
SAMPLE SELECTION:
Inclusion Criteria
* Males aged 40 - 65 year
* First diagnosis of bladder neoplasm less than 4 cm, confined in urinary bladder
* Prostate volume ≥ 40 and ≤ 80 ml with normal PSA level and obstructive voiding symptoms Exclusion Criteria
* Patients with previous prostatic, urethral surgery and urinary bladder surgery like diverticulectomy, ureteric reimplant in urinary bladder
* Patients with coagulopathy
* Previous history of heart diseases
* Diagnosis of prostate cancer
* Urethral stenosis, previous pelvic irradiation, and neurogenic bladder.
* Recurrent Bladder Tumor
DATA COLLECTION PROCEDURE:
The study involves 60 male patients diagnosed with bladder carcinoma, meeting inclusion criteria. Informed consent, emphasizing data confidentiality, will be obtained. Patients will be thoroughly examined at Jinnah Hospital Lahore. Preoperative assessment includes medical history, physical examination, digital rectal examination, PSA assay, and IPSS. Patients will be randomly assigned one of two treatments through a computer aided randomization. Patients will be followed with preoperative protocols, and undergo procedures under spinal anesthesia. In group A trans-urethral resection with a resectoscope is employed for both TURBT and TURP. In Group B TURBT, a wire loop electrode through the cystoscope removes bladder tumors in small pieces. TURP involves the resectoscope removing prostate tissue in small fragments, controlled by electrocautery. Post-surgery, complications were dealt with. Tissue fragments are sent to the lab for histopathological analysis. Follow-ups adhere to EAU guidelines, recording recurrence and UTI presence. Histopathology reports follow the 2004 WHO classification. The primary outcome recurrence rate will be noted in 3 months. All the information will be collected in a structured questionnaire.
OBJECTIVE:
The objective of the study is to compare the outcome of simultaneous trans-urethral bladder tumor and prostate resection versus trans-urethral bladder tumor resection alone in bladder tumor with prostate hyperplasia in terms of in terms of recurrence of bladder tumor SUBJECTS AND METHODS Study Design: Randomized controlled trial Settings: Department of Urology, Jinnah Hospital and Allama Iqbal Medical College, Lahore.
Study Population: Patients who will undergo TURP and TURBT at Jinnah Hospital, Lahore will be study population.
Duration of study: 3 months after approval of synopsis. Sampling Technique: Non-Probability / consecutive Sampling Sample Size: Sample size calculated with 80 % power of study and 5 % level of significance Assumed recurrence rate of simultaneous trans-urethral bladder tumor resection with prostate resection (Group A) = 53.6% Assumed recurrence rate of trans-urethral bladder tumor resection alone (Group B) = 86.9% Required sample size of total of 60 patients (30 patients in each group)
SAMPLE SELECTION:
Inclusion Criteria
* Males aged 40 - 65 year
* First diagnosis of bladder neoplasm less than 4 cm, confined in urinary bladder
* Prostate volume ≥ 40 and ≤ 80 ml with normal PSA level and obstructive voiding symptoms Exclusion Criteria
* Patients with previous prostatic, urethral surgery and urinary bladder surgery like diverticulectomy, ureteric reimplant in urinary bladder
* Patients with coagulopathy
* Previous history of heart diseases
* Diagnosis of prostate cancer
* Urethral stenosis, previous pelvic irradiation, and neurogenic bladder.
* Recurrent Bladder Tumor
DATA COLLECTION PROCEDURE:
The study involves 60 male patients diagnosed with bladder carcinoma, meeting inclusion criteria. Informed consent, emphasizing data confidentiality, will be obtained. Patients will be thoroughly examined at Jinnah Hospital Lahore. Preoperative assessment includes medical history, physical examination, digital rectal examination, PSA assay, and IPSS. Patients will be randomly assigned one of two treatments through a computer aided randomization. Patients will be followed with preoperative protocols, and undergo procedures under spinal anesthesia. In group A trans-urethral resection with a resectoscope is employed for both TURBT and TURP. In Group B TURBT, a wire loop electrode through the cystoscope removes bladder tumors in small pieces. TURP involves the resectoscope removing prostate tissue in small fragments, controlled by electrocautery. Post-surgery, complications were dealt with. Tissue fragments are sent to the lab for histopathological analysis. Follow-ups adhere to EAU guidelines, recording recurrence and UTI presence. Histopathology reports follow the 2004 WHO classification. The primary outcome recurrence rate will be noted in 3 months. All the information will be collected in a structured questionnaire.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: