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

Obturator Jerk in TURBT Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04234165
• Other study ID #: 344-(6-11-E)073-074
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: January 2020
• Source: Tribhuvan University, Nepal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Obturator Jerk in TURBT
• Urinary Bladder Neoplasms

Intervention

Device:
• TURBT
different power sources ( bipolar vs monopolar)

Locations

Country	Name	City	State
Nepal	TUTH	Kathmandu	Three

Sponsors (1)

Lead Sponsor	Collaborator
Tribhuvan University, Nepal

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	obturator jerk occurrence	occurrence of obturator jerk (yes/no) will be recorded	during TURBT
Secondary	bladder perforation(yes/no)	this parameter will be recorded during operation	during TURBT
Secondary	time of resection (minutes	this parameters will be recorded during operation	during TURBT
Secondary	TUR syndrome (yes/no)	this parameters will be recorded during and after operation	during and after operation
Secondary	decrease in hemoglobin (mg/dl)	this parameters will be recorded immediately after operation	immediate post operative period
Secondary	serum sodium(meq/l)	this parameters will be recorded immediately after operation	immediate post operative period
Secondary	need for blood transfusion (yes/no)	this parameters will be recorded immediately after operation	immediate post operative period
Secondary	clot retention (yes/no)	this parameters will be recorded immediately after operation	immediate post operative period
Secondary	presence of deep muscle (yes/no)	histo-pathology report will be evaluated for these outcome	two weeks after operation ( as per usual availability of histopathology report in the hospital)
Secondary	severy cautery artifact(yes/no)	histo-pathology report will be evaluated for these outcome	two weeks after operation ( as per usual availability of histopathology report in the hospital)