Bipolar Versus Monopolar Resection of Benign Prostate Hyperplasia

Acute Hyponatremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681471
• Other study ID #: 2012/434-992
• Status: Completed
• Phase: N/A
• First received: January 30, 2016
• Last updated: February 11, 2016
• Start date: December 2013
• Est. completion date: April 2015

Study information

• Verified date: February 2016
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Hyponatremia
• Hyperplasia
• Hyponatremia
• Prostatic Hyperplasia

Intervention

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

Device:
• monopolar resectoscope

• bipolar resectoscope TURis

Locations

Country	Name	City	State
Turkey	Meltem Savran Karadeniz	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Systolic blood pressure	mm Hg	0-3 hours	Yes
Other	Diastolic blood pressure	mm Hg	0-3 hours	Yes
Other	Heart rate	beat/min	0-3 hours	Yes
Primary	Serum sodium level	Sodium level (meq /L)	0-3 hours	Yes
Secondary	Serum osmolarity	Osmolarity (mosm/kg)	0-3 hours	Yes
Secondary	Serum potassium levels	Potassium level (meq/L)	0-3 hours	Yes
Secondary	Serum hemoglobin level	Hemoglobin level (g /dL)	0-3 hours	Yes