Bipolar Versus Monopolar Resection of Benign Prostate Hyperplasia
Primary Purpose
Acute Hyponatremia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
5% Mannitol
0,9% Sodium chloride
monopolar resectoscope
bipolar resectoscope TURis
Sponsored by
About this trial
This is an interventional treatment trial for Acute Hyponatremia focused on measuring Monopolar, Bipolar, TURP syndrome, hyponatremia
Eligibility Criteria
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
Sites / Locations
- Meltem Savran Karadeniz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Monopolar TURP
Bipolar TURP
Arm Description
Patients in Group M (Monopolar) were used monopolar resectoscope (Karl Storz, Tottling, Germany) and 5% Mannitol as an irrigation fluid.
Patients in Group B (Bipolar) were used bipolar resectoscope TURis (OLYMPUS, Tokyo, Japan) and 0,9% Sodium chloride as an irrigation fluid.
Outcomes
Primary Outcome Measures
Serum sodium level
Sodium level (meq /L)
Secondary Outcome Measures
Serum osmolarity
Osmolarity (mosm/kg)
Serum potassium levels
Potassium level (meq/L)
Serum hemoglobin level
Hemoglobin level (g /dL)
Full Information
NCT ID
NCT02681471
First Posted
January 30, 2016
Last Updated
February 11, 2016
Sponsor
Istanbul University
1. Study Identification
Unique Protocol Identification Number
NCT02681471
Brief Title
Bipolar Versus Monopolar Resection of Benign Prostate Hyperplasia
Official Title
Bipolar Versus Monopolar Resection of Benign Prostate Hyperplasia: A Comparison of the Effects on Plasma Electrolytes, Osmolarity and Hemoglobin
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hyponatremia
Keywords
Monopolar, Bipolar, TURP syndrome, hyponatremia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monopolar TURP
Arm Type
Active Comparator
Arm Description
Patients in Group M (Monopolar) were used monopolar resectoscope (Karl Storz, Tottling, Germany) and 5% Mannitol as an irrigation fluid.
Arm Title
Bipolar TURP
Arm Type
Active Comparator
Arm Description
Patients in Group B (Bipolar) were used bipolar resectoscope TURis (OLYMPUS, Tokyo, Japan) and 0,9% Sodium chloride as an irrigation fluid.
Intervention Type
Other
Intervention Name(s)
5% Mannitol
Other Intervention Name(s)
Karl Storz resectoscope
Intervention Description
Traditional monopolar TURP was performed by using and irrigation fluid containing 5% mannitol ( Resectisol Eczacibasi-Baxter).
Intervention Type
Other
Intervention Name(s)
0,9% Sodium chloride
Other Intervention Name(s)
TURis (OLYMPUS) resectoscope
Intervention Description
Bipolar TURP was carried out by using a 24 Fr TURis (OLYMPUS) resectoscope and irrigation fluid containing 0,9 % sodium chloride.
Intervention Type
Device
Intervention Name(s)
monopolar resectoscope
Intervention Type
Device
Intervention Name(s)
bipolar resectoscope TURis
Primary Outcome Measure Information:
Title
Serum sodium level
Description
Sodium level (meq /L)
Time Frame
0-3 hours
Secondary Outcome Measure Information:
Title
Serum osmolarity
Description
Osmolarity (mosm/kg)
Time Frame
0-3 hours
Title
Serum potassium levels
Description
Potassium level (meq/L)
Time Frame
0-3 hours
Title
Serum hemoglobin level
Description
Hemoglobin level (g /dL)
Time Frame
0-3 hours
Other Pre-specified Outcome Measures:
Title
Systolic blood pressure
Description
mm Hg
Time Frame
0-3 hours
Title
Diastolic blood pressure
Description
mm Hg
Time Frame
0-3 hours
Title
Heart rate
Description
beat/min
Time Frame
0-3 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meltem Savran Karadeniz, MD
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meltem Savran Karadeniz
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20345336
Citation
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.
Results Reference
result
PubMed Identifier
27777873
Citation
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.
Results Reference
derived
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Bipolar Versus Monopolar Resection of Benign Prostate Hyperplasia
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