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Safety and Efficacy of Bipolar vs Monopolar Transurethral Resection of Bladder Tumor-A Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04234165
Recruitment Status : Completed
First Posted : January 21, 2020
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Manish Pradhan, Tribhuvan University, Nepal

Tracking Information
First Submitted Date  ICMJE January 9, 2020
First Posted Date  ICMJE January 21, 2020
Last Update Posted Date January 21, 2020
Actual Study Start Date  ICMJE May 1, 2017
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2020)
obturator jerk occurrence [ Time Frame: during TURBT ]
occurrence of obturator jerk (yes/no) will be recorded
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2020)
  • bladder perforation(yes/no) [ Time Frame: during TURBT ]
    this parameter will be recorded during operation
  • time of resection (minutes [ Time Frame: during TURBT ]
    this parameters will be recorded during operation
  • TUR syndrome (yes/no) [ Time Frame: during and after operation ]
    this parameters will be recorded during and after operation
  • decrease in hemoglobin (mg/dl) [ Time Frame: immediate post operative period ]
    this parameters will be recorded immediately after operation
  • serum sodium(meq/l) [ Time Frame: immediate post operative period ]
    this parameters will be recorded immediately after operation
  • need for blood transfusion (yes/no) [ Time Frame: immediate post operative period ]
    this parameters will be recorded immediately after operation
  • clot retention (yes/no) [ Time Frame: immediate post operative period ]
    this parameters will be recorded immediately after operation
  • presence of deep muscle (yes/no) [ Time Frame: two weeks after operation ( as per usual availability of histopathology report in the hospital) ]
    histo-pathology report will be evaluated for these outcome
  • severy cautery artifact(yes/no) [ Time Frame: two weeks after operation ( as per usual availability of histopathology report in the hospital) ]
    histo-pathology report will be evaluated for these outcome
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Bipolar vs Monopolar Transurethral Resection of Bladder Tumor-A Randomized Controlled Trial
Official Title  ICMJE Safety and Efficacy of Bipolar vs Monopolar Transurethral Resection of Bladder Tumor-A
Brief Summary

Study design:

This was a single center, parallel arm, randomized, controlled trial done at Tribhuvan University Teaching Hospital,Institute Of Medicine from May 2017 to April 2018. The allocation ratio was 1:1.

Inclusion criteria: All patients undergoing Transurethral Resection of Bladder Tumor for suspected bladder tumors.

Exclusion criteria were: Consent withdrawal, bladder tumour other than in the lateral wall, unfit for spinal anesthesia and need of general anesthesia or obturator nerve block.

Methodology:

All patients suspected to have bladder cancer were subjected to imaging or cystoscopy and with confirmation of the diagnosis; they were randomized into two arms of TURBT. Spinal anesthesia was used in all cases. To overcome the potential confounding effect on our primary end point, obturator jerk, nerve block was not used.

Cystoscopy was done first and the findings were noted before proceeding to TURBT.

Tumors were resected in block from periphery to center with the stalk resected last. An additional sample of deep muscle was obtained from the tumor base and sent for histopathological examination in different containers.

All study variables were recorded in Per forma during the operation and in post operative period. Hemoglobin and sodium level was determined in immediate post operative period.

Postoperative irrigation was done with normal saline in both the resection groups and continued till the urine was clear. The catheter was removed after 48 hours in uncomplicated cases and patients were discharged. Patients were followed up in OPD at 2 weeks with the

Detailed Description

All patients suspected to have bladder cancer were subjected to imaging or cystoscopy and with confirmation of the diagnosis; they were randomized into two arms of TURBT. Spinal anesthesia was used in all cases.

To overcome the potential confounding effect on our primary end point, obturator jerk, nerve block was not used.

Cystoscopy was done first and the findings were noted before proceeding to TURBT.

Monopolar resection was done using 1.5% Glycine solution at 110 watt cutting, and 70 watt coagulation power (Covidien Valley-lab Force Fx TM) with Karl Storz 26f resectoscope and loop (8mm width and 5mm depth) with 300 telescope. Bipolar resection was done with 0.9% Normal Saline with digital impedence dependent cutting (power range 150-250 watt) and 80 watt coagulation power (Bowa Arc 400) with Karl Storz 26f resectoscope and loop (6mm width and 5mm depth) with 300 telescope.

Tumors were resected in block from periphery to center with the stalk resected last. An additional sample of deep muscle was obtained from the tumor base and sent for histopathological examination in different containers. All study variables were recorded in Per forma during the operation and in post operative period. Hemoglobin and sodium level was determined in immediate post operative period.

Postoperative irrigation was done with normal saline in both the resection groups and continued till the urine was clear. The catheter was removed after 48 hours in uncomplicated cases and patients were discharged. Patients were followed up in Out Patient Department at 2 weeks with the histopathological report for or when necessary.

Study outcome:

The incidence of obturator jerk, bladder perforation, resection time, decrease in hemoglobin and serum sodium, clot retention, need for blood transfusion, need for recoagulation and TUR syndrome were recorded for the cases in both arms. All resected specimen were evaluated by pathologist for quality by determining the presence of deep muscle in the sample and comparing the degree of cautery artifact. Severe artifact was defined as more than 50% cautery artifact in most chips.

Statistical Analysis:

Sample size (n) was calculated using 80% power and a 95% significance level for obturator jerk, assuming a 30% incidence for the monopolar system and a 5% incidence for the bipolar system. These values were arrived at after a comprehensive literature review. The sample size was determined with the formula n= K {P1(1-P1) x P2(1-P2)}/ )P1-P2)2, Where:

N= sample size P1= prevalence of obturator jerk in Monopolar TURBT P2= prevalence of obturator jerk in Bipolar TURBT K= constant (7.9 for 80% power of study and 0.05 level of significance)

A sample size of 33 in each arm was calculated using above formula. Estimating a drop out of 10%, we decided to include at least 37 patients in each arm. A computer generated random number was used to allocate eligible patients in to monopolar or bipolar resection arm. Data analysis was done using Statistical Package for Social Sciences (SPSS) version 21. Significance was determined using the independent sample t-test for quantitative variables and the chi-square test for qualitative data. P value of <0.05 was considered statistically significant.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obturator Jerk in TURBT
Intervention  ICMJE Device: TURBT
different power sources ( bipolar vs monopolar)
Study Arms  ICMJE
  • Active Comparator: Monopolar arm
    monopolar cautery was used for TURBT
    Intervention: Device: TURBT
  • Experimental: Bipolar Arm
    bipolar cautery was used for TURBT
    Intervention: Device: TURBT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2020)
70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 1, 2018
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients undergoing TURBT for suspected bladder tumors.

Exclusion Criteria:

  • Consent withdrawal, bladder tumour other than in the lateral wall, unfit for spinal anesthesia and need of general anesthesia or obturator nerve block.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nepal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04234165
Other Study ID Numbers  ICMJE 344-(6-11-E)073-074
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: online availability
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Responsible Party Manish Pradhan, Tribhuvan University, Nepal
Study Sponsor  ICMJE Tribhuvan University, Nepal
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tribhuvan University, Nepal
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP