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
NCT ID: NCT03597087
Last Updated: 2018-07-24
Study Results
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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UNKNOWN
NA
289 participants
INTERVENTIONAL
2018-07-19
2022-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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General anesthesia
Group of general anesthesia before transurethral resection of the bladder tumor anesthesia: propopol
Anesthesia before transurethral resection of the bladder tumor
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
Anesthesia
General anaesthesia : propopol
Spinal anaesthesia : bupibacaine
Spinal anesthesia
Group of spinal anesthesia before transurethral resection of the bladder tumor anesthesia: bupibacaine
Anesthesia before transurethral resection of the bladder tumor
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
Anesthesia
General anaesthesia : propopol
Spinal anaesthesia : bupibacaine
Interventions
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Anesthesia before transurethral resection of the bladder tumor
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
Anesthesia
General anaesthesia : propopol
Spinal anaesthesia : bupibacaine
Eligibility Criteria
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Inclusion Criteria
2. Patients with suspected Ta / T1 non-muscle invasive bladder cancer
3. Patients who were not previously treated with other cancers
4. Normal range creatinine, AST, ALT patients
5. Patients with both spinal anesthesia and general anesthesia
Exclusion Criteria
2. Patients with cancer other than bladder cancer or a history of treatment
3. Patients with clinical evidence of muscle-invasive bladder cancer
4. Patients taking immunosuppressive drugs and immunosuppressive drugs
18 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Ja Hyeon Ku
Professor, MD., PHD.
Principal Investigators
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Jin Tae Kim, PhD
Role: STUDY_DIRECTOR
Professor, Department of Anesthesiology, Seoul National University Hospital
Ja Hyeon Ku, PhD
Role: STUDY_CHAIR
Professor, Department of Urology, Seoul National University Hospital
Hyeong Dong Yuk, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical fellow, Department of Urology, Seoul National University Hospital
Song Hee Kim, Bacheolor
Role: PRINCIPAL_INVESTIGATOR
Researcher, Department of Urology, Seoul National University Hospital
Jae Hyun Jung, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical fellow, Department of Urology, Seoul National University Hospital
Jung Hoon Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical fellow, Department of Urology, Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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References
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Kweon TD, Lee KY. Spinal anesthesia is associated with lower recurrence rates after resection of non-muscle invasive bladder cancer. Transl Androl Urol. 2018 Apr;7(2):283-286. doi: 10.21037/tau.2018.03.13. No abstract available.
Han JH, Yuk HD, Jeong SH, Jeong CW, Kwak C, Kim JT, Ku JH. Anesthetic approaches and 2-year recurrence rates in non-muscle invasive bladder cancer: a randomized clinical trial. Reg Anesth Pain Med. 2024 Dec 31:rapm-2024-105949. doi: 10.1136/rapm-2024-105949. Online ahead of print.
Other Identifiers
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SeoulNUH_2018_TURBT
Identifier Type: -
Identifier Source: org_study_id
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