Trifecta AchievementTrifectaNCT06960135
Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy
A study testing open partial nephrectomy and laparoscopic partial nephrectomy in people with Trifecta Achievement and Pentafecta Achievement, run by South Valley University at 1 site in Egypt.
Trial summary
Background: Partial nephrectomy (PN) is a reference standard for the management of the cT1 renal mass, primarily due to better preservation of renal function. The aim of this work was to determine trifecta outcomes of open PN (OPN) and laparoscopic PN (LPN) and identify predictive factors for trifecta achievement to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trifecta Achievement, Pentafecta Achievement
- What is being tested?
- open partial nephrectomy and laparoscopic partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Mar 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • Patients who are fit for surgery.
- Patients with renal tumor who are indicated for partial nephrectomy
- Absolute:
- Solitary kidney.
- Bilateral renal tumor.
- CDK.
Show all 11Show fewer
- Relative:
- Abnormal contralateral kidney (nephropathy, nephrolithiasis, trauma).
- Metabolic disease associated with renal failure (DM, hypertension).
- Genetic syndrome with tumor multifocality (VHL syndrome). Elective
- 1. Clinical T1N0M0 Tumor. 2. Peripheral tumor.
Who cannot join
- • Patients who are unfit for surgery and who's unfit for laparoscopy.
- Patients who are contraindicated for partial nephrectomy. As severe and irreversible coagulopathy. Patients who are indicated for radical nephrectomy (extensive tumor, metastatic tumor).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors
Background: Partial nephrectomy (PN) is a reference standard for the management of the cT1 renal mass, primarily due to better preservation of renal function. The aim of this work was to determine trifecta outcomes of open PN (OPN) and laparoscopic PN (LPN) and identify predictive factors for trifecta achievement to evaluate surgical performance, including negative surgical margins, absence of severe surgical complications, and ischemia time less than 25 minutes.
Objectives: this study pointing to determine trifecta outcomes of OPN and LPN and to identify predictive factors for trifecta achievement to evaluate surgical performance, including negative surgical margins, absence of severe surgical complications, and Ischemia time less than 25 Minutes.
Read the detailed description
Methods: This prospective, randomized study was carried out on 35 patients with clinical T1 N0M0 renal tumors. Patients were divided into two groups: Group A (n=38): underwent OPN and group B (n=32): underwent LPN.
- Conditions
- Trifecta Achievement, Pentafecta Achievement
- Being tested
- open partial nephrectomy, laparoscopic partial nephrectomy
- Keywords
- Laparoscopic, Partial Nephrectomy, Trifecta, Pentafecta Achievement, Renal Tumors
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open partial nephrectomyProcedure or surgery
open partial nephrectomy
laparoscopic partial nephrectomyProcedure or surgery
laparoscopic partial nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| open partial nephrectomy | Active comparator | open partial nephrectomy Receives: Procedure: open partial nephrectomy |
| laparoscopic partial nephrectomy | Active comparator | laparoscopic partial nephrectomy Receives: Procedure: laparoscopic partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of Trifecta Achievement in Open ald Laparoscopic Partial Nephrectomy for Localised Renal Tumors
Trifecta achievement is defined as the combination of (1) negative surgical margins, (2) absence of perioperative complications classified as Clavien-Dindo grade III or higher, and (3) warm ischemia time ≤25 minutes.
factors affecting trifecta achievement among variables including tumor complexity score, patient comorbidities, BMI, surgical approches, special habbites, age or gender.
Measured: 2 years
Secondary outcomes (1)
Pentafecta Achivement
Pentafecta achievement is defined as the combination of:
- negative surgical margins,
- absence of major perioperative complications (Clavien-Dindo grade ≥III),
- warm ischemia time ≤25 minutes,
- ≥90% preservation of preoperative estimated glomerular filtration rate (eGFR), and
- no progression to a higher CKD stage at 12 months postoperative follow-up. Data will be collected from surgical, pathological, and clinical records. Predictors of Pentafecta achievement will be analyzed using multivariable logistic regression.
Measured: 2 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Jun 2022
- Primary completion30 May 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trifecta AchievementStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Ahmad Bakheet, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960135
- Sponsor's protocol ID
- SVU-MED-URO016-2-22-5-400
- Acronym
- Trifecta
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors
- ClinicalTrials.gov ID
- NCT06960135
- Acronym / sponsor ID
- Trifecta / SVU-MED-URO016-2-22-5-400
- Conditions
- Trifecta Achievement, Pentafecta Achievement
- Keywords
- Laparoscopic, Partial Nephrectomy, Trifecta, Pentafecta Achievement, Renal Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 7 May 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.
Background: Partial nephrectomy (PN) is a reference standard for the management of the cT1 renal mass, primarily due to better preservation of renal function. The aim of this work was to determine trifecta outcomes of open PN (OPN) and laparoscopic PN (LPN) and identify predictive factors for trifecta achievement to evaluate surgical performance, including negative surgical margins, absence of severe surgical complications, and ischemia time less than 25 minutes.
Objectives: this study pointing to determine trifecta outcomes of OPN and LPN and to identify predictive factors for trifecta achievement to evaluate surgical performance, including negative surgical margins, absence of severe surgical complications, and Ischemia time less than 25 Minutes.
Detailed description
Methods: This prospective, randomized study was carried out on 35 patients with clinical T1 N0M0 renal tumors. Patients were divided into two groups: Group A (n=38): underwent OPN and group B (n=32): underwent LPN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open partial nephrectomy | Active comparator | Procedure: open partial nephrectomyopen partial nephrectomy |
| laparoscopic partial nephrectomy | Active comparator | Procedure: laparoscopic partial nephrectomylaparoscopic partial nephrectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- • Patients who are fit for surgery.
- Solitary kidney.
- Bilateral renal tumor.
- CDK.
- Abnormal contralateral kidney (nephropathy, nephrolithiasis, trauma).
Key exclusion criteria (2 listed)
- • Patients who are unfit for surgery and who's unfit for laparoscopy.
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 |
|---|---|---|
| open partial nephrectomyopen partial nephrectomy | Procedure or surgery | open partial nephrectomy |
| laparoscopic partial nephrectomylaparoscopic partial nephrectomy | Procedure or surgery | laparoscopic partial nephrectomy |
Primary outcome
Predictors of Trifecta Achievement in Open ald Laparoscopic Partial Nephrectomy for Localised Renal Tumors
Time frame: 2 years
Trifecta achievement is defined as the combination of (1) negative surgical margins, (2) absence of perioperative complications classified as Clavien-Dindo grade III or higher, and (3) warm ischemia time ≤25 minutes. factors affecting trifecta achievement among variables including tumor complexity score, patient comorbidities, BMI, surgical approches, special habbites, age or gender.
1 secondary outcome
Pentafecta Achivement
Time frame: 2 yrs
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 7 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Trifecta Achievement
Not yet recruiting
Predictors of Trifecta Achievement After HoLEP
HoLEP, Trifecta Achievement
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 open partial nephrectomy and laparoscopic partial nephrectomy in people with Trifecta Achievement and Pentafecta Achievement, run by South Valley 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 11 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 7 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. 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?
Predictors of Trifecta Achievement in Open ald Laparoscopic Partial Nephrectomy for Localised Renal Tumors (time frame: 2 years). 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 7 May 2025.