Bipolar Versus Monopolar Resection of Benign Prostate Hyperplasia

Not Applicable

Completed

• Conditions: Acute Hyponatremia
• Interventions: Other: 5% Mannitol; Other: 0,9% Sodium chloride; Device: monopolar resectoscope; Device: bipolar resectoscope TURis

• Registration Number: NCT02681471
• Lead Sponsor: Istanbul University

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Study First Submitted: 2016-01-30
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-11
• Last Update Submitted: 2016-02-11
• Study First Posted: 2016-02-12
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monopolar TURP	5% Mannitol	Patients in Group M (Monopolar) were used monopolar resectoscope (Karl Storz, Tottling, Germany) and 5% Mannitol as an irrigation fluid.
Monopolar TURP	monopolar resectoscope	Patients in Group M (Monopolar) were used monopolar resectoscope (Karl Storz, Tottling, Germany) and 5% Mannitol as an irrigation fluid.
Bipolar TURP	0,9% Sodium chloride	Patients in Group B (Bipolar) were used bipolar resectoscope TURis (OLYMPUS, Tokyo, Japan) and 0,9% Sodium chloride as an irrigation fluid.
Bipolar TURP	bipolar resectoscope TURis	Patients in Group B (Bipolar) were used bipolar resectoscope TURis (OLYMPUS, Tokyo, Japan) and 0,9% Sodium chloride as an irrigation fluid.

Primary Outcome Measures

Name	Time	Method
Serum sodium level	0-3 hours	Sodium level (meq /L)

Secondary Outcome Measures

Name	Time	Method
Serum osmolarity	0-3 hours	Osmolarity (mosm/kg)
Serum hemoglobin level	0-3 hours	Hemoglobin level (g /dL)
Serum potassium levels	0-3 hours	Potassium level (meq/L)

Trial Locations

Locations (1)

Meltem Savran Karadeniz; 🇹🇷 Istanbul, Fatih, Turkey