Bakircay University Cigli Training and Research Hospital (BUCEAH)

December 19, 2020 updated by: Mustafa Ozan HORSANALI, Recep Tayyip Erdogan University Training and Research Hospital
The aim of the study is to investigate the oncological outcomes of obturator nerve blockade in patients with lateral wall localized non-muscle invasive bladder cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patient divided into two group.First group includes patients underwent TUR-BT under only spinal anesthesia and second group includes patients underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade.

Study Type

Observational

Enrollment (Actual)

106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with lateral wall localized non muscle invasive bladder cancer underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade

Description

Inclusion Criteria:

  • patients with lateral wall localized non muscle invasive bladder cancer

Exclusion Criteria:

  • history of previous TUR-BT
  • diagnosis of non-urothelial carcinoma
  • coagulopathy
  • history of allergic reaction to the local anesthtetic agent
  • presence of muscle-invasive bladder cancer
  • history of chemotherapy or radiotherapy before TUR-BT
  • precence of variant histopathology
  • using bipolar energy for the resection of bladder tumor
  • presence of concomittant upper urothelial tract urothelial carcinoma
  • patients with the neuromusculer disease
  • pregnancy
  • history of medication effecting immune system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control group
Patients underwent TUR-BT under spinal anesthesia
Procedure: Obturator nerve blockade
We performed spinal anesthesia combined with ultrasound guided obturator nerve blockade according to the localization of bladder cancer in patients with lateral wall localized non-muscle invasive bladder cancer
Study group
Patients underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade
Procedure: Obturator nerve blockade
We performed spinal anesthesia combined with ultrasound guided obturator nerve blockade according to the localization of bladder cancer in patients with lateral wall localized non-muscle invasive bladder cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncological outcomes
Time Frame: 5 year
Reccurens or progression of tumor was recorded
5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 5 years
Complications during surgery was recorded
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

December 19, 2020

First Submitted That Met QC Criteria

December 19, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Actual)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 19, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cigli

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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