Renal StoneNCT03046888
ROBOTIC PYELOLITHIOTOMY VERSUS PERCUTANEOUS NEPHROLITHOTOMY (PCNL).
A study testing Robot assisted pyelolithotomy in people with Renal Stone, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Prospectively randomized study in patients with renal pelvic stones who are candidate to standard PCNL procedure. One to one, controlled clinical trial. Patients will be randomly allocated into two groups, 20 patients in each group. Group A will be scheduled to receive routine standard PCNL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stone
- What is being tested?
- Robot assisted pyelolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2017to 13 Feb 2020
- 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
- Age above 18 years.
- Renal stones ≥2 cm.
- Patients are candidate to PCNL.
- Patient with ECOG performance score of 2 and less.
- Able to give informed consent
- Able to discharges home at the same day.
Who cannot join
- Renal stones < 2cm and can managed by another technique.
- Known with psychological disease.
Trial locations and contacts
1 site in 1 country.
About this study
Prospectively randomized study in patients with renal pelvic stones who are candidate to standard PCNL procedure. One to one, controlled clinical trial. Patients will be randomly allocated into two groups, 20 patients in each group. Group A will be scheduled to receive routine standard PCNL. Group B will be scheduled to receive Robot assisted pyelolethotomy.
- Conditions
- Renal Stone
- Being tested
- Robot assisted pyelolithotomy
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted pyelolithotomyProcedure or surgery
A 12-mm camera port is placed at the level of the umbilicus and lateral; this port is moved farther laterally in morbidly obese patients to allow for the instruments to reach the target organs. Two 8-mm robotic trocars are placed under direct vision and a 12-mm assistant port is placed in the midline a 5-8 cm above the umbilicus. For right-sided stones, an additional 5-mm port is placed in the midline just below the xiphoid process for liver retraction. Placement of the trocars can be changed according to surgeon preference. After reflecting the colon medially, the renal pelvis will be dissected and identified, a flexible cystoscope will be inserted via an assisted trocar and introduced into the renal pelvis through a minor incision. The kidney stones will then be extracted with a basket and either removed via the port or placed in a specimen retrieval bag.
| Study group | Role | What they receive |
|---|---|---|
| PCNL | Experimental | Percutant nephrolithotomy is a standard procedure for stones treatment over 2 cm.The puncture will be performed with an 18-G nephrostomy needle. The access thus gained guaranteed the transpapillary route of the percutaneous tract, a basic condition for the prevention of bleeding. Subsequently, following withdrawal of the puncture needle and urine drainage, a flexible guidewire will be inserted and advanced to the upper calyx or ureter. Receives: Procedure: Robot assisted pyelolithotomy |
| Robot assisted pyelolithotomy | Experimental | Robot assisted pyelolithotomy, is a new technique to remove stones of more than 2 cm. A 12-mm camera port is placed at the level of the umbilicus and lateral. Two 8-mm robotic trocars are placed under direct vision and a 12-mm assistant port is placed in the midline a 5-8 cm above the umbilicus. After reflecting the colon medially, the renal pelvis will be dissected and identified, a flexible cystoscope will be inserted via an assisted trocar and introduced into the renal pelvis through a minor incision. The kidney stones will then be extracted with a basket and either removed via the port or placed in a specimen retrieval bag. Receives: Procedure: Robot assisted pyelolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hospital stay
the length of hospital stay efter each procedure
Measured: 30 days
Secondary outcomes (1)
Stones free rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start1 Oct 2017
- Primary completion13 Feb 2020
- Study completion13 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StoneStudies 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
- Model description
- Prospectively randomized study in patients with renal pelvic stones who are candidate to standard PCNL procedure. One to one, controlled clinical trial. Patients will be randomly allocated into two groups, 20 patients in each group. Group A will be scheduled to receive routine standard PCNL. Group B will be scheduled to receive RP.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nessn Azawi, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046888
- Sponsor's protocol ID
- SJ-598
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2017
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROBOTIC PYELOLITHIOTOMY VERSUS PERCUTANEOUS NEPHROLITHOTOMY (PCNL).
- ClinicalTrials.gov ID
- NCT03046888
- Acronym / sponsor ID
- SJ-598
- Conditions
- Renal Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 8 Feb 2017 (estimated)
- 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.
Prospectively randomized study in patients with renal pelvic stones who are candidate to standard PCNL procedure. One to one, controlled clinical trial. Patients will be randomly allocated into two groups, 20 patients in each group. Group A will be scheduled to receive routine standard PCNL. Group B will be scheduled to receive Robot assisted pyelolethotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospectively randomized study in patients with renal pelvic stones who are candidate to standard PCNL procedure. One to one, controlled clinical trial. Patients will be randomly allocated into two groups, 20 patients in each group. Group A will be scheduled to receive routine standard PCNL. Group B will be scheduled to receive RP.
| Arm | Type | Receives |
|---|---|---|
| PCNL | Experimental | Procedure: Robot assisted pyelolithotomyPercutant nephrolithotomy is a standard procedure for stones treatment over 2 cm.The puncture will be performed with an 18-G nephrostomy needle. The access thus gained guaranteed the transpapillary route of the percutaneous tract, a basic condition for the prevention of bleeding. Subsequently, following withdrawal of the puncture needle and urine drainage, a flexible guidewire will be inserted and advanced to the upper calyx or ureter. |
| Robot assisted pyelolithotomy | Experimental | Procedure: Robot assisted pyelolithotomyRobot assisted pyelolithotomy, is a new technique to remove stones of more than 2 cm. A 12-mm camera port is placed at the level of the umbilicus and lateral. Two 8-mm robotic trocars are placed under direct vision and a 12-mm assistant port is placed in the midline a 5-8 cm above the umbilicus. After reflecting the colon medially, the renal pelvis will be dissected and identified, a flexible cystoscope will be inserted via an assisted trocar and introduced into the renal pelvis through a minor incision. The kidney stones will then be extracted with a basket and either removed via the port or placed in a specimen retrieval bag. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age above 18 years.
- Renal stones ≥2 cm.
- Patients are candidate to PCNL.
- Patient with ECOG performance score of 2 and less.
- Able to give informed consent
Key exclusion criteria (2 listed)
- Renal stones < 2cm and can managed by another technique.
- Known with psychological disease.
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 |
|---|---|---|
| Robot assisted pyelolithotomyA 12-mm camera port is placed at the level of the umbilicus and lateral; this port is moved farther laterally in morbidly obese patients to allow for the instruments to reach the target organs. Two 8-mm robotic trocars are placed under direct vision and a 12-mm assistant port is placed in the midline a 5-8 cm above the umbilicus. For right-sided stones, an additional 5-mm port is placed in the midline just below the xiphoid process for liver retraction. Placement of the trocars can be changed according to surgeon preference. After reflecting the colon medially, the renal pelvis will be dissected and identified, a flexible cystoscope will be inserted via an assisted trocar and introduced into the renal pelvis through a minor incision. The kidney stones will then be extracted with a basket and either removed via the port or placed in a specimen retrieval bag. | Procedure or surgery | PCNL, Robot assisted pyelolithotomy |
Primary outcome
Postoperative hospital stay
Time frame: 30 days
the length of hospital stay efter each procedure
1 secondary outcome
Stones free rate
Time frame: 6 months
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 17 Feb 2020.
- Individual participant dataSharing planned: No
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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 Robot assisted pyelolithotomy in people with Renal Stone, run by Zealand University Hospital at 1 site in Denmark.
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 6 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 17 Feb 2020. 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 Denmark. 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?
Postoperative hospital stay (time frame: 30 days). 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 17 Feb 2020.