Corkscrew Technique: A Novel Modification in Transurethral Resection of Large Prostate (60-100 g) Optimizing Resection Efficacy and Safety: A Double-blind Randomized Controlled Trial

NCT06901115 | Completed

• 1 other identifier: Corkscrew technique
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Transurethral resection of the prostate (TURP) is still the gold standard for surgical management of enlarged prostate. However, many techniques and minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enucleation. Multiple drawbacks of Classic TURP problems related to large prostate management as the retreatment after Bipolar resection, another issue that prolonged operative time, Loss of orientation during resection due to rotation of one of the 2 kissing lobe, Bleeding of the 1st lobe resection side make the 2nd lobe resection harder and lengthier, Median lobe resection or bladder neck resection is done at last to avoid sub-trigonal injury. however, due to median lobe obstruction, irrigation is poor during all the resection. length of learning curve, the modification of early median lobe resection carry the risk of sub-trigonal injury. So, this study is a trial to analyze the effect of new technique in resection of large prostate with good orientation and less time of operation.

Conditions

TURP(Transurethral Resection of Prostate); BPH (Benign Prostatic Hyperplasia); Prostate

Keywords

TURP; BPH; Prostate; Blandy; Nesbit

Outcome Measures

Primary Outcomes (3)

• Weight of resected tissue

  The weight of resected tissue measured in grams using laboratory scale device.

  within one hour postoperatively

• Resection time

  Resection time measured in minutes by documenting the time of resection start and time of resection end.

  the operative time

• Complication rate

  Complication rate is measured by number of complications occurred.

  the operative time

Secondary Outcomes (4)

• Change in International Prostate symptom score (IPSS)

  one month postoperatively

• Change in Qmax

  One month postoperatively

• Change in postvoid residual volume

  One month postoperatively

• Change in hemoglobin level

  One day postoperatively

Study Arms (2)

Nesbit technique group

SHAM COMPARATOR

patients of this group undergo the classical Nesbit technique.

Procedure: Nesbit technique

Corkscrew technique

ACTIVE COMPARATOR

patients of this group undergo the novel modified technique.

Procedure: Corkscrew technique

Interventions

Nesbit technique PROCEDURE

it is composed of development of trough at the right prostatic lobe (at 10 o'clock) from the bladder neck proximally down to a level just above the external urethral sphincter distally, then deepening the trough until the prostatic capsule, performing haemostasias then resection of lateral lobes in halves, upper right, lower right, upper left and at last lower left respectively with haemostasias in-between. Then resection of the median lobe if present. Final haemostasias then ensues before insertion of the triple way catheter with normal saline irrigation.

Nesbit technique group

Corkscrew technique PROCEDURE

the Corkscrew technique was performed by resection starting at 3 o'clock and carried on in a clockwise manner till 3 o'clock again. Prostate was resected from bladder neck downwards to the verumontanum after dividing the gland, imaginary, into 3 zones or thirds, proximal, middle and distal zone. The gland was resected zone by zone in this corkscrew manner. Once the proximal third is resected and hemostasis done, the middle third resection is done in the same manner, The process is repeated for the distal third. Hemostasis was performed instantly.

Corkscrew technique

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• BPH causing LUTS with prostate volume between 60 and 100 ml (either by TRUS or CT).
• PSA level below 4 ng/ml.
• IPSS score of 10 and above.

You may not qualify if:

• previous history of prostatic biopsy.
• previous history of acute urinary retention.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia Faculty of Medicine

Shebin El-Kom, Menoufia, 32511, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

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

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 28, 2025
• Study Start: November 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 28, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

EG (1)