The Difference of Two Year Recurrence Rate According to Anesthetic Method During Transurethral Resection of Bladder Mass in Patients With Non-muscle Invasive Bladder Cancer: Prospective, Randomized, Clinical Phase II Study

Study Overview
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Brief Summary
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The investigators compare the recurrence rate difference between two years after transurethral resection of the bladder tumor according to the method of anesthesia. Anesthetic methods are general anesthesia and spinal anesthesia. Assessment of recurrence is assessed by bladder endoscopy, CT, and pathological examination of surgical specimens.

Detailed Description
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Research Background Most of the bladder cancer (approximately 85%) has histologic features of urothelial carcinoma. Approximately 75% of the patients initially diagnosed as non-invasive bladder cancer (stage I, CIS) or submucosal stage T1 -muscle invasive bladder cancer - NMIBC). However, it has been reported that about 60% to 70% of patients experience recurrence and 20% to 30% of relapsed cancers require radical cystectomy or chemotherapy It is known to progress to high-grade or high grade cancer. There are studies that involve surgical factors such as volatile anesthetics, narcotic analgesics, anti-body temperature, blood transfusion, and cancer recurrence. Minimizing the use of volatile anesthetics and narcotic analgesics reduces spinal anesthesia before and after surgery, It has been reported that there is a correlation with maintenance of immune cell function Research hypothesis and purpose The aim of this study was to evaluate the recurrence rate, recurrence - free survival rate, and recurrence - free survival rate of non - muscle invasive bladder carcinoma in patients undergoing bladder resection. Research Method Preoperative screening: Physical examination, Blood test, CT urography, Urine analysis, Urine culture, Urine cytology, Cystoscopy. Enforced Randomization on the day before surgery: 289 patients were randomly assigned to a spinal anesthesia group and a general anesthesia group 1: 1. Urine analysis, urine culture, urine cytology, and cystoscopy were performed every 3 months up to 2 years postoperatively. CT urography performed once a year Follow-up procedure: Follow-up procedure according to bladder cancer standard. 4. Observation items, clinical examination items and observational examination methods Screening: CT urography, Urine analysis, Urine culture, Urine cytology, Cystoscopy. Observe Follow up: Urine analysis, Urine culture, Urine cytology, Cystoscopy every 3 months after the operation, CT urography every year

Official Title
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The Difference of Two Year Recurrence Rate According to Anesthetic Method During Transurethral Resection of Bladder Mass in Patients With Non-muscle Invasive Bladder Cancer: Prospective, Randomized, Clinical Phase II Study

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: Anesthesia before transurethral resection of the bladder tumor
* Drug: Anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older Patients with suspected Ta / T1 non-muscle invasive bladder cancer Patients who were not previously treated with other cancers Normal range creatinine, AST, ALT patients Patients with both spinal anesthesia and general anesthesia Exclusion Criteria: Patients with urinary tract carcinoma not invading the renal pelvis, ureter or urethra Patients with cancer other than bladder cancer or a history of treatment Patients with clinical evidence of muscle-invasive bladder cancer Patients taking immunosuppressive drugs and immunosuppressive drugs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After randomization, they were divided into two parallel groups 289 patients were randomly assigned to a spinal anesthesia group and a general anesthesia group 1: 1.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: General anesthesia<br>Group of general anesthesia before transurethral resection of the bladder tumor anesthesia: propopol | Procedure: Anesthesia before transurethral resection of the bladder tumor<br>* General anaesthesia or general anesthesia (see spelling differences) is a medically induced coma with loss of protective reflexes, resulting from the administration of one or more general anaesthetic agents. Spinal anaesthesia is a form of regional anaesthesia involving the injection of a local anaesthetic into the subarachnoid space, generally through a fine needle<br>Drug: Anesthesia<br>* General anaesthesia : propopol Spinal anaesthesia : bupibacaine<br>|
| Experimental: Spinal anesthesia<br>Group of spinal anesthesia before transurethral resection of the bladder tumor anesthesia: bupibacaine | Procedure: Anesthesia before transurethral resection of the bladder tumor<br>* General anaesthesia or general anesthesia (see spelling differences) is a medically induced coma with loss of protective reflexes, resulting from the administration of one or more general anaesthetic agents. Spinal anaesthesia is a form of regional anaesthesia involving the injection of a local anaesthetic into the subarachnoid space, generally through a fine needle<br>Drug: Anesthesia<br>* General anaesthesia : propopol Spinal anaesthesia : bupibacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year recurrence-free survival rate | The criteria for recurrence-free survival and recurrence of bladder cancer for 2 years postoperatively are based on pathological histology. If the recurrence is suspected in the radiological examination but pathological histological examination is difficult, the reference is based on the day of the imaging examination suspected of recurrence. | Follow up every 3 months until 2 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year progression-free survival | The progression-free survival rate and progression rate of bladder cancer for 2 years postoperatively include both T stage and tumor grade progression. | Follow up every 3 months until 2 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Bladder cancer, Recurrence rate, Transurethral resection of bladder mass