CompletedNot Applicable

Spinal Versus General Anesthesia on Coagulation and Fibrinolysis During Transurethral Resection of the Prostate

Turkey (Türkiye)78 participantsStarted 2024-10-10

Plain-language summary

This prospective randomized clinical trial aims to compare the effects of spinal and general anesthesia on perioperative coagulation and fibrinolysis in patients undergoing elective transurethral resection of the prostate (TURP). Blood samples are collected before surgery and at 1 and 24 hours postoperatively to evaluate coagulation and fibrinolytic parameters. The study also assesses perioperative hemodynamic events and postoperative complications.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male patients * Age ≥18 years * Scheduled for elective bipolar transurethral resection of the prostate * ASA physical status I-II * Ability to provide written informed consent Exclusion Criteria: * History of deep vein thrombosis or pulmonary embolism * Known inherited or acquired coagulation disorder * Severe hepatic insufficiency * Severe renal insufficiency * Use of anticoagulants, antiplatelet drugs, or NSAIDs within 10 days before surgery * Platelet count \<100 × 10⁹/L * INR \>1.5 * aPTT \>47 seconds * Contraindications to spinal anesthesia * Prostate malignancy * ASA physical status III or higher * Refusal to participate

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Prothrombin Time (PT) from Baseline to Postoperative Assessments

Timeframe: Baseline, 1 hour after surgery, and 24 hours after surgery

Change in Activated Partial Thromboplastin Time (aPTT) from Baseline to Postoperative Assessments

Timeframe: Baseline, 1 hour after surgery, and 24 hours after surgery

Change in International Normalized Ratio (INR) from Baseline to Postoperative Assessments

Timeframe: Baseline, 1 hour after surgery, and 24 hours after surgery

Change in Fibrinogen Concentration from Baseline to Postoperative Assessments

Timeframe: Baseline, 1 hour after surgery, and 24 hours after surgery

Change in D-dimer Concentration from Baseline to Postoperative Assessments

Timeframe: Baseline, 1 hour after surgery, and 24 hours after surgery

Trial details

NCT IDNCT07734233

SponsorHaseki Training and Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31

View on ClinicalTrials.gov More Benign Prostatic Hyperplasia trials