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

May 17, 2025 updated by: Ammar Fathi Mohamed AlOrabi, Menoufia University

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Menoufia
      • Shebin El-Kom, Menoufia, Egypt, 32511
        • Menoufia Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Nesbit technique group
patients of this group undergo the classical Nesbit technique.
Procedure: Nesbit technique
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.
Active Comparator: Corkscrew technique
patients of this group undergo the novel modified technique.
Procedure: Corkscrew technique
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight of resected tissue
Time Frame: within one hour postoperatively
The weight of resected tissue measured in grams using laboratory scale device.
within one hour postoperatively
Resection time
Time Frame: the operative time
Resection time measured in minutes by documenting the time of resection start and time of resection end.
the operative time
Complication rate
Time Frame: the operative time
Complication rate is measured by number of complications occurred.
the operative time

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
One month postoperatively
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.
One month postoperatively
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.
One day postoperatively
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.
one month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Corkscrew technique

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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