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Clinical Trials/NCT05330156
NCT05330156UnknownNot Applicable

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

Assiut University1 site in 1 country58 target enrollmentStarted: April 30, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
58
Locations
1
Primary Endpoint
Time of operation

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
Male
Accepts Healthy Volunteers
No

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

Arms & Interventions

Transurethral resection of the prostate group (TURP).

Active Comparator

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

Intervention: Transurethral resection of the prostate (Procedure)

transurethral enucleation of prostate group (TUEP)

Active Comparator

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

Intervention: transurethral enucleation of prostate (Procedure)

Outcomes

Primary Outcomes

Time of operation

Time Frame: intraoperative (from the start of resection or enucleation till the fixation of urethral catheter)

time used for resection or enucleation and resection of the prostate

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

AHMED FARAHAT HASSAN

principal investigator

Assiut University

Study Sites (1)

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