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

Not Applicable

Completed

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

• Registration Number: NCT06901115
• Lead Sponsor: Menoufia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-01
• Study First Submitted: 2025-03-23
• Study First Submitted QC: 2025-03-23
• Study First Posted: 2025-03-28
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-17
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight of resected tissue	within one hour postoperatively	The weight of resected tissue measured in grams using laboratory scale device.
Resection time	the operative time	Resection time measured in minutes by documenting the time of resection start and time of resection end.
Complication rate	the operative time	Complication rate is measured by number of complications occurred.

Secondary Outcome Measures

Name	Time	Method
Change in International Prostate symptom score (IPSS)	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.
Change in Qmax	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.
Change in postvoid residual volume	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.
Change in hemoglobin level	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.

Trial Locations

Locations (1)

Menoufia Faculty of Medicine; 🇪🇬 Shebin El-Kom, Menoufia, Egypt

Menoufia Faculty of Medicine

🇪🇬Shebin El-Kom, Menoufia, Egypt

Mohamed Aziz

Contact

+201097991198

Mohammed_aziz2006@yahoo.com