Transurethral Resection Versus Transurethral Enucleation of the Prostate: Prospective Randomized Study

NCT ID: NCT05330156

Last Updated: 2022-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2024-04-30

Brief Summary

TUERP technique could be used in prostates of all sizes with the same safety and efficacy "size independent procedure" . TUERP could be performed using the bipolar system only ,with or without the use of morcellator.

Detailed Description

Transurethral resection of the prostate (TURP) was first done in the 1920s. Since then, TURP has been considered as the gold standard treatment for BPH . However, its relatively high complication rate and postoperative recurrence necessitates further modification in the surgery technique .The resected adenomas have been reported to recur in up to 15% of cases that need a repeat surgical intervention, even by experienced surgeons in high-volume centers .

Before the era of TURP, simple open prostatectomy was the mainstay of surgical therapy. However, open simple prostatectomy has high risk of considerable intraoperative bleeding requiring transfusion. The lower abdominal incision done in open prostatectomy may result in significant postoperative pain, an extended recovery period and longer hospital stay, with greater morbidity and a perioperative mortality rate of 0.2%. In addition, TURP for large prostatic adenomas causes significantly much more bleeding with clot retention as compared to simple open prostatectomy, it also need a longer operative time, which leads to increased risk of TUR syndrome with subsequent morbidity . A new technique in which transurethral enucleation and resection of the prostate (TUERP) was developed and adopted to replicate the open enucleation of prostatic adenomas in an endoscopic way. This will combine the benefits of complete prostate enucleation in a minimally invasive technique . prostate enucleation by laser currently used as minimally invasive and save alternative to TURP, but still has not been widely accepted for some reasons, including high cost and prolonged learning curve.

TUERP technique could be used in prostates of all sizes with the same safety and efficacy "size independent procedure" . TUERP could be performed using the bipolar system only ,with or without the use of morcellator

Conditions

BPH

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transurethral resection of the prostate group (TURP).

the 1st group of patients will undergone Transurethral resection of the prostate for treatment of BPH

Group Type: ACTIVE_COMPARATOR

Transurethral resection of the prostate

Intervention Type: PROCEDURE

\- After an initial cysto-urethroscopy assessment done, Transurethral resection of the prostate is performed using the bipolar system with normal saline irrigation, under spinal or general anesthesia.

transurethral enucleation of prostate group (TUEP)

the 2nd group of patients will undergone Transurethral enucleation of the prostate for treatment of BPH

Group Type: ACTIVE_COMPARATOR

transurethral enucleation of prostate

Intervention Type: PROCEDURE

After an initial cysto-urethroscopy assessment done, transurethral enucleation of prostate is performed using the bipolar system with normal saline irrigation, under spinal or general anesthesia.

Interventions

Transurethral resection of the prostate

\- After an initial cysto-urethroscopy assessment done, Transurethral resection of the prostate is performed using the bipolar system with normal saline irrigation, under spinal or general anesthesia.

Intervention Type: PROCEDURE

transurethral enucleation of prostate

After an initial cysto-urethroscopy assessment done, transurethral enucleation of prostate is performed using the bipolar system with normal saline irrigation, under spinal or general anesthesia.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• -Patients aging from 50 to 80 years old who are diagnosed with clinical symptomatic BPH.
• The patients have clear indi¬cation for endoscopic surgery (according to the guidelines).
• Clinically fit patients for surgery.
• Signed an informed consent.

Exclusion Criteria

• Prostate cancer Previous urethral or prostate surgery Neurogenic bladder Urethral stricture Poor general condition of the patient

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

AHMED FARAHAT HASSAN

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MOHAMED F ABBAS, MD

Role: PRINCIPAL_INVESTIGATOR

AUH

Locations

assiut University

Asyut, , Egypt

Countries

Egypt

Central Contacts

Ahmed F Hassan, Master

Role: CONTACT

ahmedfarahat358@gmail.com

01069569946

AHMED F HASSAN

Role: CONTACT

ahmedfarahat358@gmail.com

01156522620

Other Identifiers

TURP

Identifier Type: -

Identifier Source: org_study_id