Skip to main content
OpenTrials
Completed

NCT Number: NCT06901115

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

TURP(Transurethral Resection of Prostate) BPH (Benign Prostatic Hyperplasia) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostate Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia Faculty of Medicine

Shebin El-Kom, Menoufia, 32511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Weight of resected tissue

    Time frame: within one hour postoperatively

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

  2. Resection time

    Time frame: the operative time

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

  3. Complication rate

    Time frame: the operative time

    Complication rate is measured by number of complications occurred.

Secondary outcomes

  1. Change in International Prostate symptom score (IPSS)

    Time frame: one month postoperatively

    The change in International Prostate Symptom Score (IPSS) is measured by difference between preoperative and postoperative IPSS. IPSS is measured by IPSS scoring system in form of numbers, where minimum score is 0 representing no symptoms and maximum score is 35 representing the most sever symptoms.

  2. Change in Qmax

    Time frame: One month postoperatively

    The change in IPSS score is measured by difference between preoperative and postoperative Qmax. Qmax (maximum flow rate) is measured using uroflowmetry and measured by ml/sec.

  3. Change in postvoid residual volume

    Time frame: One month postoperatively

    The change in postvoid residual volume is measured by difference between preoperative and postoperative postvoid residual volume. postvoid residual volume is assessed using pelviabdominal ultrasound and measured by centimeter cubic.

  4. Change in hemoglobin level

    Time frame: One day postoperatively

    The change in hemoglobin is measured by difference between preoperative and postoperative hemoglobin level. Hemoglobin level is assessed using Complete Blood Count and measured by g/dl.

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 28, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.