Clinical trial · Interventional
Spinal Versus General Anesthesia in Open Simple Prostatectomy
Effect of Spinal Versus General Anesthesia on Postoperative Bleeding in Patients Undergoing Open Simple Prostatectomy: A Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Open simple prostatectomy is still performed for selected patients with benign prostatic hyperplasia, particularly in cases with large prostate volume. Postoperative bleeding, hematuria, clot retention, and transfusion requirement are clinically important complications after this procedure. This prospective randomized controlled trial will compare the effects of spinal anesthesia and general anesthesia on postoperative bleeding in patients undergoing open simple prostatectomy. Participants will be randomized into two groups: spinal anesthesia or general anesthesia. Tranexamic acid or any additional hemostatic agent will not be used. Postoperative bleeding will be assessed using hemoglobin and hematocrit changes, transfusion requirement, hematuria, clot retention, need for bladder irrigation, and bleeding-related reintervention. The study aims to determine whether spinal anesthesia is associated with reduced postoperative bleeding compared with general anesthesia in open simple prostatectomy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anesthesia | — | UNRESOLVED | — |
| Benign Prostatic Hyperplasia | Benign Prostatic Hyperplasia | ONTOLOGY_EXACT | 0.98 |
| Urologic Neoplasms | Urinary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| General anesthesia | Procedure | — | UNRESOLVED |
| Spinal anesthesia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Spinal Anesthesia
- description
- Participants allocated to this arm will receive spinal anesthesia for open simple prostatectomy according to the institutional standard anesthesia protocol.
- interventionNames
- Procedure: Spinal anesthesia
- type
- ACTIVE_COMPARATOR
- label
- General Anesthesia
- description
- Participants allocated to this arm will receive general anesthesia for open simple prostatectomy according to the institutional standard anesthesia protocol.
- interventionNames
- Procedure: General anesthesia
Primary outcomes (1)
- measure
- Clinically Significant Postoperative Bleeding
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male patients aged 18 years or older. * Diagnosis of benign prostatic hyperplasia (BPH). * Scheduled to undergo open simple prostatectomy. * American Society of Anesthesiologists (ASA) physical status I-III. * Ability to provide written informed consent. Exclusion Criteria: * Refusal or inability to provide informed consent. * Patients scheduled for radical prostatectomy due to prostate cancer. * Emergency surgery. * Known coagulation disorders or clinically significant thrombocytopenia. * Ongoing anticoagulant or antiplatelet therapy that cannot be discontinued according to institutional protocols. * Contraindication to spinal anesthesia. * Participation in another interventional clinical trial that may affect study outcomes. * Administration of tranexamic acid or any additional hemostatic agent during the perioperative period.
References
Publications (0)
Data not yet available