Clinical trial NCT02681471: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Hyponatremia
Keywords: Monopolar
Bipolar
TURP syndrome
hyponatremia
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 53
Sex: MALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Serum sodium level
timeFrame: 0-3 hours
Secondary outcomes:
measure: Serum osmolarity
timeFrame: 0-3 hours
measure: Serum potassium levels
timeFrame: 0-3 hours
measure: Serum hemoglobin level
timeFrame: 0-3 hours
Other outcomes:
measure: Systolic blood pressure
timeFrame: 0-3 hours
measure: Diastolic blood pressure
timeFrame: 0-3 hours
measure: Heart rate
timeFrame: 0-3 hours
Locations:
city: Istanbul
country: Turkey
facility: Meltem Savran Karadeniz
state: Fatih
Study officials:
affiliation: Istanbul University
name: Meltem Savran Karadeniz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.