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

BPH Clinical Trial

— Prostate  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05330156
• Other study ID #: TURP
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2022
• Source: Assiut University
• Contact: Ahmed F Hassan, Master
• Phone: 01069569946
• Email: ahmedfarahat358[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: April 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• BPH

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of operation	time used for resection or enucleation and resection of the prostate	intraoperative (from the start of resection or enucleation till the fixation of urethral catheter)