TURP(Transurethral Resection of Prostate)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
A study testing Nesbit technique and Corkscrew technique in people with TURP(Transurethral Resection of Prostate) and BPH (Benign Prostatic Hyperplasia), run by Menoufia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- TURP(Transurethral Resection of Prostate), BPH (Benign Prostatic Hyperplasia), Prostate
- What is being tested?
- Nesbit technique and Corkscrew technique
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 28 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- previous history of prostatic biopsy.
- previous history of acute urinary retention.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Nesbit technique, Corkscrew technique
- Keywords
- TURP, BPH, Prostate, Blandy, Nesbit
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nesbit techniqueProcedure or surgery
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 techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Nesbit technique group | Sham comparator | patients of this group undergo the classical Nesbit technique. Receives: Procedure: Nesbit technique |
| Corkscrew technique | Active comparator | patients of this group undergo the novel modified technique. Receives: Procedure: Corkscrew technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight of resected tissue
The weight of resected tissue measured in grams using laboratory scale device.
Measured: within one hour postoperatively
Resection time
Resection time measured in minutes by documenting the time of resection start and time of resection end.
Measured: the operative time
Complication rate
Complication rate is measured by number of complications occurred.
Measured: the operative time
Secondary outcomes (4)
Change in International Prostate symptom score (IPSS)
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.
Measured: one month postoperatively
Change in Qmax
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.
Measured: One month postoperatively
Change in postvoid residual volume
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.
Measured: One month postoperatively
Change in hemoglobin level
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.
Measured: One day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Nov 2024
- Primary completion1 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TURP(Transurethral Resection of Prostate)Studies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Fathi Mohamed AlOrabi, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901115
- Sponsor's protocol ID
- Corkscrew technique
- Status last verified
- May 2025
- First submitted
- 23 Mar 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06901115
- Acronym / sponsor ID
- Corkscrew technique
- Keywords
- TURP, BPH, Prostate, Blandy, Nesbit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nesbit technique group | Sham comparator | Procedure: Nesbit techniquepatients of this group undergo the classical Nesbit technique. |
| Corkscrew technique | Active comparator | Procedure: Corkscrew techniquepatients of this group undergo the novel modified technique. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- previous history of prostatic biopsy.
- previous history of acute urinary retention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nesbit techniqueit 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. | Procedure or surgery | Nesbit technique group |
| Corkscrew techniquethe 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. | Procedure or surgery | Corkscrew technique |
Primary outcome
Weight of resected tissue
Time frame: within one hour postoperatively
The weight of resected tissue measured in grams using laboratory scale device.
Resection time
Time frame: the operative time
Resection time measured in minutes by documenting the time of resection start and time of resection end.
Complication rate
Time frame: the operative time
Complication rate is measured by number of complications occurred.
4 secondary outcomes
Change in International Prostate symptom score (IPSS)
Time frame: one month postoperatively
Change in Qmax
Time frame: One month postoperatively
Change in postvoid residual volume
Time frame: One month postoperatively
Change in hemoglobin level
Time frame: One day postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nesbit technique and Corkscrew technique in people with TURP(Transurethral Resection of Prostate) and BPH (Benign Prostatic Hyperplasia), run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight of resected tissue (time frame: within one hour postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.