Acute HyponatremiaNCT02681471
Bipolar Versus Monopolar Resection of Benign Prostate Hyperplasia
A study testing 5% Mannitol, 0,9% Sodium chloride and monopolar resectoscope in people with Acute Hyponatremia, run by Istanbul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years, men only
- Conditions the study is for
- Acute Hyponatremia
- What is being tested?
- 5% Mannitol, 0,9% Sodium chloride and monopolar resectoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men were older than 50 years
- Men suffered from symptomatic benign prostatic hyperplasia.
Who cannot join
- History of severe heart failure
- History of respiratory failure
- History of bleeding diathesis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Meltem Savran Karadeniz
Istanbul, Fatih, 34000
About this study
Official title: 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).
Read the 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.
- Conditions
- Acute Hyponatremia
- Being tested
- 5% Mannitol, 0,9% Sodium chloride, monopolar resectoscope, bipolar resectoscope TURis
- Keywords
- Monopolar, Bipolar, TURP syndrome, hyponatremia
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% MannitolOther
Also called Karl Storz resectoscope
Traditional monopolar TURP was performed by using and irrigation fluid containing 5% mannitol ( Resectisol Eczacibasi-Baxter).
0,9% Sodium chlorideOther
Also called TURis (OLYMPUS) resectoscope
Bipolar TURP was carried out by using a 24 Fr TURis (OLYMPUS) resectoscope and irrigation fluid containing 0,9 % sodium chloride.
monopolar resectoscopeDevice
bipolar resectoscope TURisDevice
| Study group | Role | What they receive |
|---|---|---|
| Monopolar TURP | Active comparator | Patients in Group M (Monopolar) were used monopolar resectoscope (Karl Storz, Tottling, Germany) and 5% Mannitol as an irrigation fluid. Receives: Other: 5% Mannitol; Device: monopolar resectoscope |
| Bipolar TURP | Active comparator | Patients in Group B (Bipolar) were used bipolar resectoscope TURis (OLYMPUS, Tokyo, Japan) and 0,9% Sodium chloride as an irrigation fluid. Receives: Other: 0,9% Sodium chloride; Device: bipolar resectoscope TURis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum sodium level
Sodium level (meq /L)
Measured: 0-3 hours
Secondary outcomes (3)
Serum osmolarity
Osmolarity (mosm/kg)
Measured: 0-3 hours
Serum potassium levels
Potassium level (meq/L)
Measured: 0-3 hours
Serum hemoglobin level
Hemoglobin level (g /dL)
Measured: 0-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startDec 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute HyponatremiaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
- Investigators
- Meltem Savran Karadeniz, MD, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681471
- Sponsor's protocol ID
- 2012/434-992
- Status last verified
- Feb 2016
- First submitted
- 30 Jan 2016
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 20345336Karadeniz 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.
PubMed 27777873
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Versus Monopolar Resection of Benign Prostate Hyperplasia: A Comparison of the Effects on Plasma Electrolytes, Osmolarity and Hemoglobin
- ClinicalTrials.gov ID
- NCT02681471
- Acronym / sponsor ID
- 2012/434-992
- Conditions
- Acute Hyponatremia
- Keywords
- Monopolar, Bipolar, TURP syndrome, hyponatremia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monopolar TURP | Active comparator | Other: 5% Mannitol, Device: monopolar resectoscopePatients in Group M (Monopolar) were used monopolar resectoscope (Karl Storz, Tottling, Germany) and 5% Mannitol as an irrigation fluid. |
| Bipolar TURP | Active comparator | Other: 0,9% Sodium chloride, Device: bipolar resectoscope TURisPatients in Group B (Bipolar) were used bipolar resectoscope TURis (OLYMPUS, Tokyo, Japan) and 0,9% Sodium chloride as an irrigation fluid. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men were older than 50 years
- Men suffered from symptomatic benign prostatic hyperplasia.
Key exclusion criteria (3 listed)
- History of severe heart failure
- History of respiratory failure
- History of bleeding diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% MannitolAlso: Karl Storz resectoscopeTraditional monopolar TURP was performed by using and irrigation fluid containing 5% mannitol ( Resectisol Eczacibasi-Baxter). | Other | Monopolar TURP |
| 0,9% Sodium chlorideAlso: TURis (OLYMPUS) resectoscopeBipolar TURP was carried out by using a 24 Fr TURis (OLYMPUS) resectoscope and irrigation fluid containing 0,9 % sodium chloride. | Other | Bipolar TURP |
| monopolar resectoscope | Device | Monopolar TURP |
| bipolar resectoscope TURis | Device | Bipolar TURP |
Primary outcome
Serum sodium level
Time frame: 0-3 hours
Sodium level (meq /L)
3 secondary outcomes
Serum osmolarity
Time frame: 0-3 hours
Serum potassium levels
Time frame: 0-3 hours
Serum hemoglobin level
Time frame: 0-3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Results publication: PubMed 20345336Michielsen 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.
- Derived from this study: PubMed 27777873Karadeniz 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.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Hyponatremia
RecruitingPhase 4
CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS
Critical Care, Intensive Care, Fluid Accumulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meltem Savran Karadeniz, MD principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5% Mannitol, 0,9% Sodium chloride and monopolar resectoscope in people with Acute Hyponatremia, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum sodium level (time frame: 0-3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02681471, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.