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

Bladder Cancer Clinical Trial

Official title: 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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

1. 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

2. 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.

3. 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 ;

Related Conditions & MeSH terms

• Bladder Cancer
• Recurrence
• Urinary Bladder Neoplasms

• NCT number: NCT03597087
• Study type: Interventional
• Source: Seoul National University Hospital
• Contact: Hyeong Dong Yuk, MD
• Phone: +82-2-2072-1968
• Email: hinayuk@naver.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 19, 2018
• Completion date: December 31, 2022