Comparison of Different Energy Sources During TUR-P

November 15, 2019 updated by: Murat AKAND, Selcuk University

Comparison of Two Different Bipolar and A Monopolar Energy Sources During Transurethral Resection of Prostate

With this study, it is aimed to compare the operative results and complication rates in transurethral resection of the prostate (TUR-P) performed by resectoscopes with two different bipolar and a monopolar energy sources.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Following data will be collected and evaluated prospectively for the three groups of patients who will undergo TUR-P due to benign prostate hyperplasia (BPH) with one of the resectoscopes using different energy sources:

  1. Preoperative data: age, height, weight, body-mass index, concomitant morbidities, use of any drug, history of operation, duration of lower urinary tract symptoms, history of any previous treatment taken for BPH, serum level of prostate specific antigen, prostate volume, maximum and average urine flow rate, postmicturation residual urine volume, hemoglobin level
  2. Operative data: duration of operation, volume of resected tissue, observation of obturator reflex (if any), kind and size of the urethral catheter used
  3. Postoperative data: time to removal of urethral catheter, hospitalization duration, change in hemoglobin, rate of blood transfusion, any other complications

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42075
        • Selcuk University, School of Medicine, Department of Urology

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Having an indication due to BPH
  • Aged between 40 and 80 years old

Exclusion Criteria:

  • Kidney failure due to BPH
  • Any kind of coagulopathy or use of anticoagulants in the preoperative period
  • History of any previous open or endoscopic prostate surgery

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bipolar TURP-1
Transurethral resection of prostate (TURP) with bipolar resectoscope (Gyrus brand)
Procedure: Bipolar TURP-1
Bipolar transurethral resection of prostate (TURP)
Active Comparator: Bipolar TURP-2
TURP with bipolar resectoscope (Olympus brand)
Procedure: Bipolar TURP-2
Bipolar TURP
Active Comparator: Monopolar TURP
TURP with monopolar resectoscope (Karl Storz brand)
Procedure: Monopolar TURP
Monopolar TURP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uroflowmetry test
Time Frame: Within the first 30 days after surgery.
Determining the improvement in maximal urine flow (mL/s) and average urine flow (mL/s).
Within the first 30 days after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall complication rates
Time Frame: Within the first 30 days after surgery.
Number of patients with any complications related with TURP (including hemorrhage, blood transfusion, urinary tract infections, urethral strictures) classified according to modified Clavien-Dindo classification.
Within the first 30 days after surgery.

Collaborators and Investigators

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

Sponsor

Selcuk University

Investigators

  • Principal Investigator: Murat Akand, MD, Selcuk University, School of Medicine, Department of Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

August 23, 2015

First Submitted That Met QC Criteria

August 24, 2015

First Posted (Estimate)

August 27, 2015

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-TURP-BM-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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