Large Renal StoneNCT06394219
A Comparative Study Between Anterior and Posterior Pyelotomy in Transperitoneal Laparoscopic Pyelolithotomy
A study testing traditional transperitoneal laparoscopic pyelolithotomy and modified transperitoneal laparoscopic pyelolithotomy in people with Large Renal Stone, run by Damascus University at 1 site in Syria.
Trial summary
Large renal pelvic stones are frequently managed with percutaneous nephrolithotomy (PCNL) but laparoscopic pyelolithotomy (LPL) can be an alternative procedure when performed by skilled surgeons to achieve excellent outcomes in terms of stone free status, operative time, postoperative kidney function, hospitalization… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Large Renal Stone
- What is being tested?
- traditional transperitoneal laparoscopic pyelolithotomy and modified transperitoneal laparoscopic pyelolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSyria
- Study dates
- 1 Jan 2022to 1 Apr 2024
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with large renal pelvic stone > 2 cm .
- failure of minimally invasive approaches such as PCNL or ESWL
- stones that were neither amenable to ESWL nor were ideally suitable for PCNL
- Patient's preference for a quick one-stage procedure.
- Negative urine culture
Who cannot join
- Patients refusing study participation.
- Contraindication to general anesthesia.
- Contraindication to laparoscopic surgery.
- Patients with an intrarenal pelvis.
- Previous surgical on the same kidney.
- Associated anatomical deformity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transperitoneal Laparoscopic Pyelolithotomy: Is the Posterior Pyelotomy Better Than the Anterior? (A Randomized Controlled Clinical Trial)
Large renal pelvic stones are frequently managed with percutaneous nephrolithotomy (PCNL) but laparoscopic pyelolithotomy (LPL) can be an alternative procedure when performed by skilled surgeons to achieve excellent outcomes in terms of stone free status, operative time, postoperative kidney function, hospitalization duration, and complications.
there are two methods for LPL surgery : Transperitoneal (TLP) and Retroperitoneal (RLP).
Read more
RLP associated with shorter mean time for oral intake, and mean hospital stay after surgery.
The surgical exposure in the transperitoneal route for LP is familiar to the majority of surgeons. Also, a much larger working space is available and there are various established anatomical landmarks for performing the surgery effectively. This study introduces a modified technique that creates application of posterior pyelotomy in TLP to achieve the advantages of RLP
Read the detailed description
This is a randomized controlled clinical trial that aims to collect a sample within two years from the date of approval of the Scientific Research Council at Damascus University.
The study will focus on a group of patients who will undergo a transperitoneal laparoscopic pyelolithotomy surgery.
The patients will be randomly divided into two groups. The first group will undergo a traditional transperitoneal laparoscopic pyelolithotomy, which involves application of anterior pyelotomy.
The second group will receive a modified transperitoneal laparoscopic pyelolithotomy, which involves application of posterior pyelotomy.
The data will be compared between the two groups in terms of the mean duration of surgery ,mean time for oral intake ,and mean hospital stay
- Conditions
- Large Renal Stone
- Being tested
- traditional transperitoneal laparoscopic pyelolithotomy, modified transperitoneal laparoscopic pyelolithotomy
- Keywords
- Pyelotomy, Laparoscopic Pyelolithotomy,, pelvic stone, kidney stone
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional transperitoneal laparoscopic pyelolithotomyProcedure or surgery
Also called TLP
Performing anterior Pyelotomy.
modified transperitoneal laparoscopic pyelolithotomyProcedure or surgery
Performing posterior pyelotomy
| Study group | Role | What they receive |
|---|---|---|
| Anterior Pyelotomy | Experimental | Traditional transperitoneal laparoscopic pyelolithotomy:
Patients who were randomized to receive classic transperitoneal laparoscopic pyelolithotomy Receives: Procedure: traditional transperitoneal laparoscopic pyelolithotomy |
| Posterior Pyelotomy | Experimental | Modified transperitoneal laparoscopic pyelolithotomy:
Patients who were randomized to receive modified transperitoneal laparoscopic pyelolithotomy by applying posterior pyelotomy. Receives: Procedure: modified transperitoneal laparoscopic pyelolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
the duration of the surgical procedure. It is measured by minutes, and calculated from establishing the pneumoperitoneum until the surgery is completed by suturing the skin.
It will be measured in the outcome by the mean
Measured: at the end of surgery in the operating room
Days for oral intake
the number of days to start introducing oral fluids and food after surgery with good acceptance, and without vomiting or flatulence.
It will be measured in the outcome by the mean
Measured: Up to one week after surgery
Days of hospital stay
the number of days the patient stayed in the hospital after surgery. It will be measured in the outcome by the mean
Measured: up to ten days after surgery
Postoperative urine leak
considered to be present when the drain contained >30 cc of urine the morning after surgery.
It is measured by answering the question: Is there any urinary leakage, yes or no? It will be measured in the outcome by the ratio
Measured: up to three days after surgery
stone-free status
postoperative radiological imaging demonstrating evidence of residual stones It will be measured in the Outcome by the ratio
Measured: Up to one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Jan 2022
- Primary completion1 Jan 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Large 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394219
- Sponsor's protocol ID
- Posterior Pyelotomy
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soltani MH, Hossein Kashi A, Farshid S, Mantegy SJ, Valizadeh R. Transperitoneal Laparoscopic Pyelolithotomy versus Percutaneous Nephrolithotomy for Treating the Patients with Staghorn Kidney Stones: A Randomized Clinical Trial. Urol J. 2021 Dec 20;19(1):28-33. doi: 10.22037/uj.v18i.6831.
PubMed 34927230Bai Y, Tang Y, Deng L, Wang X, Yang Y, Wang J, Han P. Management of large renal stones: laparoscopic pyelolithotomy versus percutaneous nephrolithotomy. BMC Urol. 2017 Aug 31;17(1):75. doi: 10.1186/s12894-017-0266-7.
PubMed 28859655Al-Hunayan A, Abdulhalim H, El-Bakry E, Hassabo M, Kehinde EO. Laparoscopic pyelolithotomy: is the retroperitoneal route a better approach? Int J Urol. 2009 Feb;16(2):181-6. doi: 10.1111/j.1442-2042.2008.02210.x. Epub 2008 Dec 2.
PubMed 19183229Gaur DD, Agarwal DK, Purohit KC, Darshane AS. Retroperitoneal laparoscopic pyelolithotomy. J Urol. 1994 Apr;151(4):927-9. doi: 10.1016/s0022-5347(17)35124-8.
PubMed 8126827Radfar MH, Dadpour M, Simforoosh N, Basiri A, Nouralizadeh A, Shakiba B, Valipour R, Zare A. Laparoscopic pyelolithotomy in patients with previous ipsilateral renal stone surgery. Urologia. 2021 Feb;88(1):41-45. doi: 10.1177/0391560319890993. Epub 2019 Dec 23.
PubMed 31868562Wang X, Li S, Liu T, Guo Y, Yang Z. Laparoscopic pyelolithotomy compared to percutaneous nephrolithotomy as surgical management for large renal pelvic calculi: a meta-analysis. J Urol. 2013 Sep;190(3):888-93. doi: 10.1016/j.juro.2013.02.092. Epub 2013 Feb 27.
PubMed 23454154
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transperitoneal Laparoscopic Pyelolithotomy: Is the Posterior Pyelotomy Better Than the Anterior? (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06394219
- Acronym / sponsor ID
- Posterior Pyelotomy
- Conditions
- Large Renal Stone
- Keywords
- Pyelotomy, Laparoscopic Pyelolithotomy,, pelvic stone, kidney stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 1 May 2024 (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.
Large renal pelvic stones are frequently managed with percutaneous nephrolithotomy (PCNL) but laparoscopic pyelolithotomy (LPL) can be an alternative procedure when performed by skilled surgeons to achieve excellent outcomes in terms of stone free status, operative time, postoperative kidney function, hospitalization duration, and complications.
there are two methods for LPL surgery : Transperitoneal (TLP) and Retroperitoneal (RLP).
RLP associated with shorter mean time for oral intake, and mean hospital stay after surgery.
The surgical exposure in the transperitoneal route for LP is familiar to the majority of surgeons. Also, a much larger working space is available and there are various established anatomical landmarks for performing the surgery effectively. This study introduces a modified technique that creates application of posterior pyelotomy in TLP to achieve the advantages of RLP
Detailed description
This is a randomized controlled clinical trial that aims to collect a sample within two years from the date of approval of the Scientific Research Council at Damascus University.
The study will focus on a group of patients who will undergo a transperitoneal laparoscopic pyelolithotomy surgery.
The patients will be randomly divided into two groups. The first group will undergo a traditional transperitoneal laparoscopic pyelolithotomy, which involves application of anterior pyelotomy.
The second group will receive a modified transperitoneal laparoscopic pyelolithotomy, which involves application of posterior pyelotomy.
The data will be compared between the two groups in terms of the mean duration of surgery ,mean time for oral intake ,and mean hospital stay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Pyelotomy | Experimental | Procedure: traditional transperitoneal laparoscopic pyelolithotomyTraditional transperitoneal laparoscopic pyelolithotomy: Patients who were randomized to receive classic transperitoneal laparoscopic pyelolithotomy |
| Posterior Pyelotomy | Experimental | Procedure: modified transperitoneal laparoscopic pyelolithotomyModified transperitoneal laparoscopic pyelolithotomy: Patients who were randomized to receive modified transperitoneal laparoscopic pyelolithotomy by applying posterior pyelotomy. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with large renal pelvic stone > 2 cm .
- failure of minimally invasive approaches such as PCNL or ESWL
- stones that were neither amenable to ESWL nor were ideally suitable for PCNL
- Patient's preference for a quick one-stage procedure.
- Negative urine culture
Key exclusion criteria (6 listed)
- Patients refusing study participation.
- Contraindication to general anesthesia.
- Contraindication to laparoscopic surgery.
- Patients with an intrarenal pelvis.
- Previous surgical on the same kidney.
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 |
|---|---|---|
| traditional transperitoneal laparoscopic pyelolithotomyAlso: TLPPerforming anterior Pyelotomy. | Procedure or surgery | Anterior Pyelotomy |
| modified transperitoneal laparoscopic pyelolithotomyPerforming posterior pyelotomy | Procedure or surgery | Posterior Pyelotomy |
Primary outcome
Operative time
Time frame: at the end of surgery in the operating room
the duration of the surgical procedure. It is measured by minutes, and calculated from establishing the pneumoperitoneum until the surgery is completed by suturing the skin. It will be measured in the outcome by the mean
Days for oral intake
Time frame: Up to one week after surgery
the number of days to start introducing oral fluids and food after surgery with good acceptance, and without vomiting or flatulence. It will be measured in the outcome by the mean
Days of hospital stay
Time frame: up to ten days after surgery
the number of days the patient stayed in the hospital after surgery. It will be measured in the outcome by the mean
Postoperative urine leak
Time frame: up to three days after surgery
considered to be present when the drain contained >30 cc of urine the morning after surgery. It is measured by answering the question: Is there any urinary leakage, yes or no? It will be measured in the outcome by the ratio
stone-free status
Time frame: Up to one week after surgery
postoperative radiological imaging demonstrating evidence of residual stones It will be measured in the Outcome by the ratio
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 1 May 2024.
- Background: PubMed 34927230Soltani MH, Hossein Kashi A, Farshid S, Mantegy SJ, Valizadeh R. Transperitoneal Laparoscopic Pyelolithotomy versus Percutaneous Nephrolithotomy for Treating the Patients with Staghorn Kidney Stones: A Randomized Clinical Trial. Urol J. 2021 Dec 20;19(1):28-33. doi: 10.22037/uj.v18i.6831.
- Background: PubMed 28859655Bai Y, Tang Y, Deng L, Wang X, Yang Y, Wang J, Han P. Management of large renal stones: laparoscopic pyelolithotomy versus percutaneous nephrolithotomy. BMC Urol. 2017 Aug 31;17(1):75. doi: 10.1186/s12894-017-0266-7.
- Background: PubMed 19183229Al-Hunayan A, Abdulhalim H, El-Bakry E, Hassabo M, Kehinde EO. Laparoscopic pyelolithotomy: is the retroperitoneal route a better approach? Int J Urol. 2009 Feb;16(2):181-6. doi: 10.1111/j.1442-2042.2008.02210.x. Epub 2008 Dec 2.
- Background: PubMed 8126827Gaur DD, Agarwal DK, Purohit KC, Darshane AS. Retroperitoneal laparoscopic pyelolithotomy. J Urol. 1994 Apr;151(4):927-9. doi: 10.1016/s0022-5347(17)35124-8.
- Background: PubMed 31868562Radfar MH, Dadpour M, Simforoosh N, Basiri A, Nouralizadeh A, Shakiba B, Valipour R, Zare A. Laparoscopic pyelolithotomy in patients with previous ipsilateral renal stone surgery. Urologia. 2021 Feb;88(1):41-45. doi: 10.1177/0391560319890993. Epub 2019 Dec 23.
- Background: PubMed 23454154Wang X, Li S, Liu T, Guo Y, Yang Z. Laparoscopic pyelolithotomy compared to percutaneous nephrolithotomy as surgical management for large renal pelvic calculi: a meta-analysis. J Urol. 2013 Sep;190(3):888-93. doi: 10.1016/j.juro.2013.02.092. Epub 2013 Feb 27.
- 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 traditional transperitoneal laparoscopic pyelolithotomy and modified transperitoneal laparoscopic pyelolithotomy in people with Large Renal Stone, run by Damascus University at 1 site in Syria.
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 5 inclusion and 6 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 1 May 2024. 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 Syria. 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?
Operative time (time frame: at the end of surgery in the operating room). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06394219, which also lists 6 linked publications.
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 1 May 2024.