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

NCT04234165 | Completed

• 1 other identifier: 344-(6-11-E)073-074
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Obturator Jerk in TURBT

Outcome Measures

Primary Outcomes (1)

• obturator jerk occurrence

  occurrence of obturator jerk (yes/no) will be recorded

  during TURBT

Secondary Outcomes (9)

• bladder perforation(yes/no)

  during TURBT

• time of resection (minutes

  during TURBT

• TUR syndrome (yes/no)

  during and after operation

• decrease in hemoglobin (mg/dl)

  immediate post operative period

• serum sodium(meq/l)

  immediate post operative period

Study Arms (2)

Monopolar arm

ACTIVE COMPARATOR

monopolar cautery was used for TURBT

Device: TURBT

Bipolar Arm

EXPERIMENTAL

bipolar cautery was used for TURBT

Device: TURBT

Interventions

TURBT DEVICE

different power sources ( bipolar vs monopolar)

Bipolar Arm; Monopolar arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing TURBT for suspected bladder tumors.

You may not qualify if:

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

Sponsors & Collaborators

• Tribhuvan University, Nepal: lead

Study Sites (1)

TUTH

Kathmandu, Three, 44600, Nepal

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Lectuerer

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 21, 2020
• Study Start: May 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

NE (1)