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Completed

NCT Number: NCT02681471

Bipolar Versus Monopolar Resection of Benign Prostate Hyperplasia

Aim of this prospective clinical study was to compare two different surgical techniques and used solutions on serum electrolytes, bleeding and Transurethral Resection of Prostate (TURP) syndrome undergoing TURP.

Fifty-three patients scheduled for elective TURP were enrolled in this prospective clinical study. Patients were included one of two groups (Group Monopolar and Group Bipolar).

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Key information

Age range

50 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Meltem Savran Karadeniz

Istanbul, Fatih, 34000, Turkey (Türkiye)

About this study

Background and Purpose:

Aim of this prospective clinical study was to compare two different surgical techniques and used solutions on serum electrolytes, bleeding and Transurethral Resection of Prostate (TURP) syndrome undergoing TURP.

Methods:

Fifty-three patients scheduled for elective TURP were enrolled in this prospective clinical study. Patients were divided into two groups. Patients in Group M (Monopolar) (n=25) were used monopolar resectoscope (Karl Storz, Tottling, Germany) and 5% mannitol as irrigating solution. Patients in Group B (Bipolar) (n=25) were used bipolar resectoscope TURis (OLYMPUS, Tokyo, Japan) and isotonic saline as irrigating solution. Patients who received spinal anaesthesia were given 2.5-3 ml 0.5% hyperbaric bupivacain intrathecally and others were given general anaesthesia. Patients demographics, prostate volumes, hemodynamic parameters, volumes of irrigation and IV solutions were recorded. Blood samples were collected preoperatively (control), 45 minutes after the induction (2nd Measurement) and 1 hour after the end of the operation for analyzing serum electrolytes, osmolarity, hemoglobin values.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men were older than 50 years
  • Men suffered from symptomatic benign prostatic hyperplasia.

Exclusion criteria

  • History of severe heart failure
  • History of respiratory failure
  • History of bleeding diathesis

Treatment and study plan

5% Mannitol

Other

Traditional monopolar TURP was performed by using and irrigation fluid containing 5% mannitol ( Resectisol Eczacibasi-Baxter).

Other names: Karl Storz resectoscope

0,9% Sodium chloride

Other

Bipolar TURP was carried out by using a 24 Fr TURis (OLYMPUS) resectoscope and irrigation fluid containing 0,9 % sodium chloride.

Other names: TURis (OLYMPUS) resectoscope

monopolar resectoscope

Device

bipolar resectoscope TURis

Device

Primary outcomes

  1. Serum sodium level

    Time frame: 0-3 hours

    Sodium level (meq /L)

Secondary outcomes

  1. Serum osmolarity

    Time frame: 0-3 hours

    Osmolarity (mosm/kg)

  2. Serum potassium levels

    Time frame: 0-3 hours

    Potassium level (meq/L)

  3. Serum hemoglobin level

    Time frame: 0-3 hours

    Hemoglobin level (g /dL)

Other outcomes

  1. Systolic blood pressure

    Time frame: 0-3 hours

    mm Hg

  2. Diastolic blood pressure

    Time frame: 0-3 hours

    mm Hg

  3. Heart rate

    Time frame: 0-3 hours

    beat/min

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Bipolar Versus Monopolar Resection of Benign Prostate Hyperplasia: A Comparison of the Effects on Plasma Electrolytes, Osmolarity and Hemoglobin

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 12, 2016
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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