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

NCT04234165 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-01-21

No results posted yet for this study

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

Interventions

DEVICE

TURBT

different power sources ( bipolar vs monopolar)

Sponsors & Collaborators

  • Tribhuvan University, Nepal

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-04-01
Completion
2018-11-01

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04234165 on ClinicalTrials.gov