Bipolar Versus Monopolar Resection of Benign Prostate Hyperplasia

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

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).

Study Overview

• Status: Completed
• Conditions: Acute Hyponatremia
• Intervention / Treatment: Other: 5% Mannitol; Device: monopolar resectoscope; Other: 0,9% Sodium chloride; Device: bipolar resectoscope TURis

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34000
      • Meltem Savran Karadeniz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Monopolar TURP; Patients in Group M (Monopolar) were used monopolar resectoscope (Karl Storz, Tottling, Germany) and 5% Mannitol as an irrigation fluid.	Other: 5% Mannitol; Traditional monopolar TURP was performed by using and irrigation fluid containing 5% mannitol ( Resectisol Eczacibasi-Baxter).; Other Names: Karl Storz resectoscope; Device: monopolar resectoscope
Active Comparator: Bipolar TURP; Patients in Group B (Bipolar) were used bipolar resectoscope TURis (OLYMPUS, Tokyo, Japan) and 0,9% Sodium chloride as an irrigation fluid.	Other: 0,9% Sodium chloride; 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; Device: bipolar resectoscope TURis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum sodium level	Sodium level (meq /L)	0-3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum osmolarity	Osmolarity (mosm/kg)	0-3 hours
Serum potassium levels	Potassium level (meq/L)	0-3 hours
Serum hemoglobin level	Hemoglobin level (g /dL)	0-3 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	mm Hg	0-3 hours
Diastolic blood pressure	mm Hg	0-3 hours
Heart rate	beat/min	0-3 hours

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Meltem Savran Karadeniz, MD, Istanbul University

Publications and helpful links

General Publications

• Michielsen DP, Coomans D, Braeckman JG, Umbrain V. Bipolar transurethral resection in saline: the solution to avoid hyponatraemia and transurethral resection syndrome. Scand J Urol Nephrol. 2010 Sep;44(4):228-35. doi: 10.3109/00365591003720275.
• Karadeniz MS, Bayazit E, Aksoy O, Salviz EA, Tefik T, Sanli O, Sungur MO, Tugrul KM. Bipolar versus monopolar resection of benign prostate hyperplasia: a comparison of plasma electrolytes, hemoglobin and TUR syndrome. Springerplus. 2016 Oct 7;5(1):1739. doi: 10.1186/s40064-016-3407-7. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: January 30, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 12, 2016

Study Record Updates

• Last Update Posted (Estimate): February 12, 2016
• Last Update Submitted That Met QC Criteria: February 11, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Monopolar; Bipolar; TURP syndrome; hyponatremia
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Prostatic Diseases; Water-Electrolyte Imbalance; Prostatic Hyperplasia; Hyperplasia; Hyponatremia; Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: 2012/434-992

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
• product manufactured in and exported from the U.S.: No