Anesthesia Type and HoLEP Outcomes: A Multi-Center Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorOndokuz Mayıs University
About this trial
1. What is this study about, and why is it required?
The goal of this observational study is to learn if anesthesia type (e.g., general anesthesia, spinal anesthesia) affects the safety and efficiency of HoLEP surgery. The main question it aims to answer is:
\- Is a particular type of anesthesia related to less or more bleeding during the surgery? 2. What will be assessed to answer the main question of this study? (Outcome measure(s))
2.1. Primary outcome measure of this study is:
\- Change in the hemoglobin level perioperatively.
2.2. Secondary outcome measures are: * Requirement for the usage of any vasoactive medication due to low blood pressure * Time passed until discharge. * Time passed until the removal of the bladder drainage catheter. * Ratio of the unwanted events that require additional intervention other than medication, fluids, or blood transfusions (Complications, Clavien-Dindo Grade III or higher). * International symptom questionnaire score 3 months after surgery. * Quality of life (QoL) score 3 months after surgery. * Peak urinary current velocity (Qmax) and post-void residual volume measurement 3 months after surgery. 3. Can anyone participate in this study?
Voluntary participants should meet the following criteria:
* Being older than 18 years old. * Having bothersome lower urinary tract symptoms due to prostatic enlargement requiring surgical treatment. * Having no untreated or uncontrolled systemic disease, which refers to having an ASA (American Society of Anesthesiologists Physical Status Classification System) score III at most.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older men who have BPO requiring surgical treatment.
Participants who can give written informed consent.
Having no more than 3 points for the American Society of Anesthesiologists (ASA) physical status classification scale (ASA 1 to 3).
Disqualifiers
Absolute contraindication for spinal or general anesthesia
History of previous surgery for prostate (e.g., surgery for prostate cancer, surgery for benign prostate obstruction)
Uncorrected bleeding disorder (INR > 1.5)
Participants who are not willing to give informed consent.
Trial population
Male patients undergoing HoLEP for BPO.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
320 Participants
are grouped into 2 trial groupsGroup A: General Anesthesia
Group B: Spinal Anesthesia
Trial outcomes
Primary outcomes
1
Hemoglobin change
Difference between preoperative and postoperative hemoglobin levels (g/dL)
Time frame
First day after HoLEP is performed.Secondary outcomes
1
International Prostate Symptom with quality of life score (IPSS-QoL) at 3 months after surgery
The severity of lower urinary tract symptoms and their impact on quality of life should be assessed using a validated questionnaire. * 0 to 35 points for IPSS * 0 to 6 points for QoL Scale variable.
Time frame
At 3 months after HoLEP2
Duration of hospitalization
Day(s) passed until discharge after HoLEP.
Time frame
Postoperative second to seventh days after HoLEP.3
Duration of catheterization
Day(s) passed until the removal of the bladder drainage catheter after HoLEP.
Time frame
From the time of HoLEP until the removal of the catheter.4
Ratio of high grade complications
Complications will be classified according to the Clavien-Dindo classification. Clavien-Dindo Grade III or higher is considered a high-grade complication.
Time frame
From the time of HoLEP to 30 days after HoLEP.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: