Spinal Versus General Anesthesia in Open Simple Prostatectomy

NCT07643415 | Recruiting

• 1 other identifier: 2026-18
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Urologic Neoplasms; Benign Prostatic Hyperplasia; Anesthesia

Keywords

Open simple prostatectomy, spinal anesthesia, general anesthesia, postoperative bleeding

Outcome Measures

Primary Outcomes (1)

• Clinically Significant Postoperative Bleeding

  Clinically significant postoperative bleeding is defined as the occurrence of at least one of the following events: Requirement for red blood cell transfusion; Hemoglobin decrease ≥2 g/dL accompanied by persistent gross hematuria and/or ongoing bladder irrigation; Clot retention requiring intensified bladder irrigation or endoscopic clot evacuation; Bleeding-related reintervention.

  Within 72 hours after surgery

Study Arms (2)

Spinal Anesthesia

ACTIVE COMPARATOR

Participants allocated to this arm will receive spinal anesthesia for open simple prostatectomy according to the institutional standard anesthesia protocol.

Procedure: Spinal anesthesia

General Anesthesia

ACTIVE COMPARATOR

Participants allocated to this arm will receive general anesthesia for open simple prostatectomy according to the institutional standard anesthesia protocol.

Procedure: General anesthesia

Interventions

Spinal anesthesia PROCEDURE

Spinal anesthesia will be performed at the L3-4 or L4-5 interspace under aseptic conditions using hyperbaric bupivacaine. Light sedation may be administered when clinically required.

Spinal Anesthesia

General anesthesia PROCEDURE

General anesthesia will be induced and maintained according to the institutional standard protocol. Airway management, mechanical ventilation, anesthetic maintenance, antiemetic prophylaxis, and multimodal analgesia will be applied according to routine clinical practice.

General Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study includes only male participants because benign prostatic hyperplasia and open simple prostatectomy are conditions and procedures specific to individuals with a prostate gland.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit university

Çorum, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urologic Neoplasms; Prostatic Hyperplasia; Postoperative Hemorrhage

Interventions

Anesthesia, Spinal; Anesthesia, General

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Ozgur Yağan, Professor

  Hitit University

  STUDY CHAIR

Central Study Contacts

Mustafa Serdar Çağlayan

CONTACT

+905074311951; serdar.09.09@hotmail.com

Sibel Onen Ozdemir

CONTACT

+905442892194; sibelonen89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)