Bladder CancerNCT04839029
Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT
A study testing Bipolar En bloc TURBT and Monopolar En bloc TURBT in people with Bladder Cancer and Bladder Neoplasm, run by Benha University at 1 site in Egypt.
Trial summary
Non-muscle invasive bladder cancers (NMIBC) compose about 80% of bladder tumors. the stranded treatment of these tumors is TURBT. en bloc resection of NMIBC yields better mascularis propria with better oncological outcomes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Bladder Neoplasm
- What is being tested?
- Bipolar En bloc TURBT and Monopolar En bloc TURBT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 1 Sep 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed primary NMIBC (Ta, Tis, T1)
- Age > 18 years
Who cannot join
- MIBC
- anterior located mass ( difficult or non visualized)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Banha university hospital
Banhā, Qalyubia Governorate, 13511
About this study
Official title: Bipolar Versus Monopolar Needlescopic En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer: A Prospective Randomized Study
Non-muscle invasive bladder cancers (NMIBC) compose about 80% of bladder tumors. the stranded treatment of these tumors is TURBT.
en bloc resection of NMIBC yields better mascularis propria with better oncological outcomes
- Conditions
- Bladder Cancer, Bladder Neoplasm
- Being tested
- Bipolar En bloc TURBT, Monopolar En bloc TURBT
- Keywords
- NMIBC, TURBT, En bloc resection
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar En bloc TURBTProcedure or surgery
patients subjected to Bipolar resection of bladder tumor by Collins loop
Monopolar En bloc TURBTProcedure or surgery
patients subjected to Monopolar resection of bladder tumor by Collins loop (hot Knife)
| Study group | Role | What they receive |
|---|---|---|
| Bipolar En bloc TURBT | Experimental | patient subjected to bipolar Needlescopic En bloc resection of NMIBC Receives: Procedure: Bipolar En bloc TURBT |
| Monopolar En bloc TURBT | Active comparator | patient subjected to Monopolar Needlescopic En bloc resection of NMIBC Receives: Procedure: Monopolar En bloc TURBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of tumor Resection
presence of detrusor muscle
Measured: immediatly post operative
adequacy of tumor Resection
Presence of residual tumor at the bed of previously resected NMIBC
Measured: 2 to 6 weeks postoprative
Secondary outcomes (1)
Complications
Modified Clavien-Dindo classification scale
Measured: within 30 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Nov 2019
- Primary completion30 Aug 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Benha 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed El-Shaer, MD, Benha University
- Investigators
- Waleed El-Shaer, M.D, Principal investigator, Faculty of medicine, Banha university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839029
- Sponsor's protocol ID
- IDIRB2017122601-293
- Status last verified
- Jul 2022
- First submitted
- 7 Apr 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Versus Monopolar Needlescopic En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04839029
- Acronym / sponsor ID
- IDIRB2017122601-293
- Conditions
- Bladder Cancer, Bladder Neoplasm
- Keywords
- NMIBC, TURBT, En bloc resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 9 Apr 2021 (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.
Non-muscle invasive bladder cancers (NMIBC) compose about 80% of bladder tumors. the stranded treatment of these tumors is TURBT.
en bloc resection of NMIBC yields better mascularis propria with better oncological outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar En bloc TURBT | Experimental | Procedure: Bipolar En bloc TURBTpatient subjected to bipolar Needlescopic En bloc resection of NMIBC |
| Monopolar En bloc TURBT | Active comparator | Procedure: Monopolar En bloc TURBTpatient subjected to Monopolar Needlescopic En bloc resection of NMIBC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- confirmed primary NMIBC (Ta, Tis, T1)
- Age > 18 years
Key exclusion criteria (2 listed)
- MIBC
- anterior located mass ( difficult or non visualized)
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 |
|---|---|---|
| Bipolar En bloc TURBTpatients subjected to Bipolar resection of bladder tumor by Collins loop | Procedure or surgery | Bipolar En bloc TURBT |
| Monopolar En bloc TURBTpatients subjected to Monopolar resection of bladder tumor by Collins loop (hot Knife) | Procedure or surgery | Monopolar En bloc TURBT |
Primary outcome
Quality of tumor Resection
Time frame: immediatly post operative
presence of detrusor muscle
adequacy of tumor Resection
Time frame: 2 to 6 weeks postoprative
Presence of residual tumor at the bed of previously resected NMIBC
1 secondary outcome
Complications
Time frame: within 30 days post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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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.
Waleed El-Shaer, M.D principal investigator
Faculty of medicine, Banha university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar En bloc TURBT and Monopolar En bloc TURBT in people with Bladder Cancer and Bladder Neoplasm, run by Benha 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 2 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: status not confirmed, as of the sponsor's last update on 19 Jul 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waleed El-Shaer, M.D (01015767331 ext. 0020, waleed_elshaer@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of tumor Resection (time frame: immediatly post operative). The study lists 2 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 19 Jul 2022.