Transurethral Plasmakinetic Enucleation of Prostate Versus Transurethral Resection of Prostate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-11

Study Completion Date

2021-06-01

Brief Summary

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The study is a multicentric randomized control trial with 4-year follow-up comparing perioperative and postoperative outcomes for transurethral plasmakinetic enucleation of prostate(TUKEP) and transurethral resection of prostate(TURP). The investigators recruit patient with benign prostatic hyperplasia(BPH) as the object of study. TURP is set as control group . Meanwhile TUKEP is set as test group. Six affiliated hospitals will participate in this study. Through analyzing the perioperative and postoperative data between TUKEP group and TURP group, The investigators purpose demonstrating superiority of safety, efficacy and economic benefit in TUKEP group.

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Detailed Description

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Benign prostatic hyperplasia (BPH) is the most common disease of middle aged and elderly people which cause urinary tract symptoms (LUTS). transurethral resection of prostate(TURP) , began to replace the traditional open surgery in 1930s, still is as the "gold standard" operation for surgical treatment of BPH. However, compared with the traditional open operation, TURP has the following flaws:(1), due to the incomplete resection , maximum flow rate(Qmax) after TURP is lower than Qmax after open surgery. (2), there are serious complications, such as water intoxication and hemorrhage. (3) TURP has limitation to large prostate.

Transurethral plasmakinetic enucleation of prostate(TUKEP), an operation mode devised by Liu Chunxiao Team in southern medical university urology department, have offset the advantage of TURP. The theory of the operation is using transurethral resectoscope instead of the finger in the open operation, to find the surgical capsule of prostate and to peel the hyperplastic prostate gland visually in a antidromic way. One the one hand, TUKEP effectively solve the situation that It should repeatedly cut and stop bleeding and difficultly find the surgical capsule in TURP, which obviously reduce the rate of bleeding, prostatic capsula perforation, transurethral resection syndrome(TURS) and External sphincter injury. On the other hand, TUKEP is the minimally invasive surgery. It also achieves the effect of open surgery resolving the residual gland and reoperation post TURP.

The investigators plan to setup a a multicentric randomized control trial with 4-year follow-up comparing perioperative and postoperative outcomes for TUKEP and TURP. Through analyzing the perioperative and postoperative data between TUKEP group and TURP group, The purpose demonstrating superiority of safety, efficacy and economic benefit in TUKEP group.

Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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TUKEP(enucleation of prostate)

Patients accept TUKEP (transurethral plasmakinetic enucleation of prostate). The TUKEP procedure requires the use of a resectoscope, camera system and irrigation fluid. The system consists of a generator unit and a wire loop with an electrical current running, the beak of resectoscope was used to enucleation of prostate and the bipolar loop was used to cutting and coagulation, There are many manufacturers of Bipolar TURP systems. Any bipolar plasmakinetic system approved by the CFDA (Chinese food and drug administration) may be used for the study.

The bipolar plasmakinetic system was set at 160 W for cutting and 100 W for coagulation.

Group Type ACTIVE_COMPARATOR

Transurethral plasmakinetic enucleation of prostate

Intervention Type PROCEDURE

Transurethral plasmakinetic enucleation of prostate(PAKEP),an operation mode devised by Liu Chunxiao Team in southern medical university urology department. The theory of the operation is using transurethral resectoscope instead of the finger in the open operation, to find the surgical capsule of prostate and to peel the hyperplastic prostate gland visually in a antidromic way.

TURP(resection of prostate)

Patients accept TURP (transurethral resection of prostate). The TURP procedure requires the use of a resectoscope, camera system and irrigation fluid. The system consists of a generator unit and a wire loop with an electrical current running through the loop used to cut prostate tissue and cauterize. Prostate tissue is cut away in small pieces and removed at the end of the procedure using irrigation. There are many manufacturers of TURP systems. Any monopolar and bipolar loop system approved by the CFDA (Chinese food and drug administration) may be used for the study.

The bipolar plasmakinetic system was set at 160 W for cutting and 100 W for coagulation.

Group Type ACTIVE_COMPARATOR

transurethral resection of prostate

Intervention Type PROCEDURE

Transurethral resection of prostate(TURP), a kind of mature minimally invasive surgery of prostate , taking the place of the traditional open surgery in 1930s , still is the "gold standard" operation for surgical treatment of BPH.

Interventions

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Transurethral plasmakinetic enucleation of prostate

Transurethral plasmakinetic enucleation of prostate(PAKEP),an operation mode devised by Liu Chunxiao Team in southern medical university urology department. The theory of the operation is using transurethral resectoscope instead of the finger in the open operation, to find the surgical capsule of prostate and to peel the hyperplastic prostate gland visually in a antidromic way.

Intervention Type PROCEDURE

transurethral resection of prostate

Transurethral resection of prostate(TURP), a kind of mature minimally invasive surgery of prostate , taking the place of the traditional open surgery in 1930s , still is the "gold standard" operation for surgical treatment of BPH.

Intervention Type PROCEDURE

Other Intervention Names

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TUKEP TURP

Eligibility Criteria

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Inclusion Criteria

1. Diagnose as BPH
2. Between 50 and 80 year-old
3. Prostate volume less than 120g
4. Meet any conditions (1). International Prostate Symptom Score (IPSS),≥12 quality of life score (QOL) ≥4分 (2).Maximum urinary flow rate (Qmax) 15 ml/s or less (urine flow more than 150 ml) (3).Medication is not efficient (4).Repeated urinary retention (extubation failure more than one) (5).Schafer≥grade 2
5. The American association of anesthesia score (ASA) class 1 to 3
6. Sign the informed consent voluntarily and will be willing to follow-up

Exclusion Criteria

1. Combined with central nervous system lesions (such as cerebrovascular accident, Parkinson, multiple sclerosis, cauda equina injury, spinal cord lesions, etc.) and neurogenic bladder;
2. The combination of advanced malignant tumor or chronic wasting disease;
3. Patients with severe cardiopulmonary disease or severe mental disorders;
4. Acute urinary tract infection, urethral stricture;
5. There is a history of prostate and bladder surgery;
6. Combined with severe coagulopathy;
7. Postoperative pathology confirmed prostate cancer;
8. Poor compliance, and can not be followed up.

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No