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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

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


Condition or disease Intervention/treatment Phase
Obturator Jerk in TURBT Device: TURBT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Bipolar vs Monopolar Transurethral Resection of Bladder Tumor-A
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Active Comparator: Monopolar arm
monopolar cautery was used for TURBT
Device: TURBT
different power sources ( bipolar vs monopolar)

Experimental: Bipolar Arm
bipolar cautery was used for TURBT
Device: TURBT
different power sources ( bipolar vs monopolar)




Primary Outcome Measures :
  1. obturator jerk occurrence [ Time Frame: during TURBT ]
    occurrence of obturator jerk (yes/no) will be recorded


Secondary Outcome Measures :
  1. bladder perforation(yes/no) [ Time Frame: during TURBT ]
    this parameter will be recorded during operation

  2. time of resection (minutes [ Time Frame: during TURBT ]
    this parameters will be recorded during operation

  3. TUR syndrome (yes/no) [ Time Frame: during and after operation ]
    this parameters will be recorded during and after operation

  4. decrease in hemoglobin (mg/dl) [ Time Frame: immediate post operative period ]
    this parameters will be recorded immediately after operation

  5. serum sodium(meq/l) [ Time Frame: immediate post operative period ]
    this parameters will be recorded immediately after operation

  6. need for blood transfusion (yes/no) [ Time Frame: immediate post operative period ]
    this parameters will be recorded immediately after operation

  7. clot retention (yes/no) [ Time Frame: immediate post operative period ]
    this parameters will be recorded immediately after operation

  8. 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

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04234165


Locations
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Nepal
TUTH
Kathmandu, Three, Nepal, 44600
Sponsors and Collaborators
Tribhuvan University, Nepal
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Responsible Party: Manish Pradhan, Urology Lectuerer, Tribhuvan University, Nepal
ClinicalTrials.gov Identifier: NCT04234165    
Other Study ID Numbers: 344-(6-11-E)073-074
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: online availability
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases