Stone, KidneyRIRSNCT06860113
Evaluation of Retrograde Intra Renal Surgery in the T-tilted Position
A study testing T-tilting of the patient during surgery and standard lithotomy position in people with Stone, Kidney, run by Ain Shams University at 1 site in Egypt.
Trial summary
To evaluate the effect of the T-tilted position on the stone-free rate compared to the standard lithotomy position in retrograde intrarenal surgeries. Common positions include the Trendelenburg position, where the patient is tilted head-down to help gravity move stones from the upper calyces to the renal pelvis, and… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stone, Kidney
- What is being tested?
- T-tilting of the patient during surgery and standard lithotomy position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients above the age of 16 years of either sex who did not have a pre-existing ureteral stent presented to the Urology clinic in our university hospitals with kidney stones with size up to 2.5cm (estimated by CTUT as the greatest dimension or the summation of the greatest dimensions).
Who cannot join
- Previous open renal surgery or renal trauma.
- Patients with renal anomalies.
- Patients with untreated or active UTI.
- Patients who suffer from medical conditions that preclude the application of Trendelenburg position (lung disease, congestive heart failure).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
AinShams university hospitals
Cairo, Abbassia, Cairo
Emad Tawfeik, +2001210235447, emadmamdouh676@gmail.com
About this study
Official title: Evaluation of the T-tilted Position in Retrograde Intrarenal Surgery Using Flexible and Navigable Suction Access Sheath.
To evaluate the effect of the T-tilted position on the stone-free rate compared to the standard lithotomy position in retrograde intrarenal surgeries.
Common positions include the Trendelenburg position, where the patient is tilted head-down to help gravity move stones from the upper calyces to the renal pelvis, and the modified lateral decubitus position, which improves access to the lower renal poles. A more recent approach, the modified T-tilt position, combines a slight Trendelenburg tilt with lateral positioning, offering optimal access to both the upper and lower calyces while maintaining patient comfort
Read the detailed description
Retrograde intrarenal surgery is a minimally invasive technique for managing renal stones, especially those in the renal pelvis and calyces. It is the standard of care for renal stones less than 2 cm. Due to the new advancements in endoscopes, ureteral access sheaths, and laser devices,retrograde intra renal surgery has been successful in managing stones with larger sizes.
The stone-free rate following flexible ureteroscopy for renal stones smaller than 2 cm is generally high, with most studies reporting stone free ratio between 80% and 95%.
Variations in stone free ratio can be attributed to factors such as stone composition, location, surgeon experience, intraoperative complications, type of laser and endoscopies Anatomical variations of the kidney especially The stone free ratio is mainly related to stone volume. The more the stone volume and greater risk of residual stones.
suction sheath was developed to enhance the stone free ratio and lower incidence of residual fragments.
Patients position was suggest to lower the postoperative residual rate. Common positions include the Trendelenburg position, where the patient is tilted head-down to help gravity move stones from the upper calyces to the renal pelvis, and the modified lateral decubitus position, which improves access to the lower renal poles. A more recent approach, the modified T-tilt position, combines a slight Trendelenburg tilt with lateral positioning, offering optimal access to both the upper and lower calyces while maintaining patient comfort.
We aimed throughout our study to evaluate the impact of the T-tilted position on stone free rate in retrograde intra renal surgery using flexible suction sheath.
METHODS This study aims to compare two patient positioning techniques during retrograde intrarenal surgery to assess their impact on the stone-free rate. Patients will be randomly assigned to one of two groups: Group A (standard lithotomy position) and Group B (T-Tilt position). The allocation process will use sealed envelopes prepared by an independent third party to ensure unbiased distribution. Both patients and the research team, including data collectors and statisticians, will be blinded to the intervention type to minimize bias. The study will evaluate whether the T-Tilt position improves stone free rate compared to the traditional lithotomy position, potentially optimizing retrograde intra renal surgery outcomes.
Surgical procedure The study will involve a consistent surgical approach to minimize variability. All procedures will be conducted under general anesthesia, with preoperative evaluation based on the American Society of Anesthesiologists physical status classification. Each patient will undergo cystourethroscopy, followed by selective catheterization with a 6F ureteric catheter. The main surgical procedure will be flexible ureteroscopy, performed according to the surgeon's standard technique, without special maneuvers like stone displacement. For patients with large stone burdens, an access sheath will be used to facilitate efficient stone removal. Stone characteristics, including size, location, and renal anatomy, will be recorded for analysis.
At the end of the procedure, an endoscopic examination of the pelvicalyceal system will be performed to assess stone fragmentation and the presence of residual fragments or dust. This examination will be video-recorded for post-operative assessment. The primary outcome of the study will be the comparison of stone free rate between the two positioning groups, while secondary outcomes will include the evaluation of perioperative complications, operative time, postoperative pain, hospital stay, and cost analysis.
- Conditions
- Stone, Kidney
- Being tested
- T-tilting of the patient during surgery, standard lithotomy position
- Keywords
- stone free rate, suction sheath
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-tilting of the patient during surgeryProcedure or surgery
Patients will be placed at the T-Tilt position (15 degrees Trendelenburg and 15 degrees away from the surgical side kidney) during surgery.
standard lithotomy positionProcedure or surgery
Patients will be placed in regular lithotomy position with operating table at 0 degrees of tilting.
| Study group | Role | What they receive |
|---|---|---|
| standard group | Other | Patients will be placed in regular lithotomy position with operating table at 0 degrees of tilting. Receives: Procedure: standard lithotomy position |
| T-tilted group | Experimental | Patients will be placed at the T-Tilt position (15 degrees Trendelenburg and 15 degrees away from the surgical side kidney). Receives: Procedure: T-tilting of the patient during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate in the T-tilted position during surgery
Follow up visits will be scheduled after 2 weeks; computed tomography urinary tract (CTUT) will be performed to identify stone-free rates and the procedure will be considered successful if no stones can be identified >4mm.
Measured: the duration of the study of at least 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Mar 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stone, KidneyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad mamdouh adly tawfeik, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860113
- Sponsor's protocol ID
- RIRS in T-tilted position
- Acronym
- RIRS
- Status last verified
- Jul 2025
- First submitted
- 21 Feb 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Yuan Y, Liang YN, Li KF, Ho YR, Wu QL, Zhao Z. A meta-analysis: retrograde intrarenal surgery vs. percutaneous nephrolithotomy in children. Front Pediatr. 2023 May 2;11:1086345. doi: 10.3389/fped.2023.1086345. eCollection 2023.
PubMed 37205217Liaw CW, Khusid JA, Gallante B, Bamberger JN, Atallah WM, Gupta M. The T-Tilt Position: A Novel Modified Patient Position to Improve Stone-Free Rates in Retrograde Intrarenal Surgery. J Urol. 2021 Nov;206(5):1232-1239. doi: 10.1097/JU.0000000000001948. Epub 2021 Jul 12.
PubMed 34251886Pan J, Xue W, Xia L, Zhong H, Zhu Y, Du Z, Chen Q, Huang Y. Ureteroscopic lithotripsy in Trendelenburg position for proximal ureteral calculi: a prospective, randomized, comparative study. Int Urol Nephrol. 2014 Oct;46(10):1895-901. doi: 10.1007/s11255-014-0732-z. Epub 2014 May 14.
PubMed 24824146Hyams ES, Munver R, Bird VG, Uberoi J, Shah O. Flexible ureterorenoscopy and holmium laser lithotripsy for the management of renal stone burdens that measure 2 to 3 cm: a multi-institutional experience. J Endourol. 2010 Oct;24(10):1583-8. doi: 10.1089/end.2009.0629.
PubMed 20629566
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the T-tilted Position in Retrograde Intrarenal Surgery Using Flexible and Navigable Suction Access Sheath.
- ClinicalTrials.gov ID
- NCT06860113
- Acronym / sponsor ID
- RIRS / RIRS in T-tilted position
- Conditions
- Stone, Kidney
- Keywords
- stone free rate, suction sheath
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Mar 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.
To evaluate the effect of the T-tilted position on the stone-free rate compared to the standard lithotomy position in retrograde intrarenal surgeries.
Common positions include the Trendelenburg position, where the patient is tilted head-down to help gravity move stones from the upper calyces to the renal pelvis, and the modified lateral decubitus position, which improves access to the lower renal poles. A more recent approach, the modified T-tilt position, combines a slight Trendelenburg tilt with lateral positioning, offering optimal access to both the upper and lower calyces while maintaining patient comfort
Detailed description
Retrograde intrarenal surgery is a minimally invasive technique for managing renal stones, especially those in the renal pelvis and calyces. It is the standard of care for renal stones less than 2 cm. Due to the new advancements in endoscopes, ureteral access sheaths, and laser devices,retrograde intra renal surgery has been successful in managing stones with larger sizes.
The stone-free rate following flexible ureteroscopy for renal stones smaller than 2 cm is generally high, with most studies reporting stone free ratio between 80% and 95%.
Variations in stone free ratio can be attributed to factors such as stone composition, location, surgeon experience, intraoperative complications, type of laser and endoscopies Anatomical variations of the kidney especially The stone free ratio is mainly related to stone volume. The more the stone volume and greater risk of residual stones.
suction sheath was developed to enhance the stone free ratio and lower incidence of residual fragments.
Patients position was suggest to lower the postoperative residual rate. Common positions include the Trendelenburg position, where the patient is tilted head-down to help gravity move stones from the upper calyces to the renal pelvis, and the modified lateral decubitus position, which improves access to the lower renal poles. A more recent approach, the modified T-tilt position, combines a slight Trendelenburg tilt with lateral positioning, offering optimal access to both the upper and lower calyces while maintaining patient comfort.
We aimed throughout our study to evaluate the impact of the T-tilted position on stone free rate in retrograde intra renal surgery using flexible suction sheath.
METHODS This study aims to compare two patient positioning techniques during retrograde intrarenal surgery to assess their impact on the stone-free rate. Patients will be randomly assigned to one of two groups: Group A (standard lithotomy position) and Group B (T-Tilt position). The allocation process will use sealed envelopes prepared by an independent third party to ensure unbiased distribution. Both patients and the research team, including data collectors and statisticians, will be blinded to the intervention type to minimize bias. The study will evaluate whether the T-Tilt position improves stone free rate compared to the traditional lithotomy position, potentially optimizing retrograde intra renal surgery outcomes.
Surgical procedure The study will involve a consistent surgical approach to minimize variability. All procedures will be conducted under general anesthesia, with preoperative evaluation based on the American Society of Anesthesiologists physical status classification. Each patient will undergo cystourethroscopy, followed by selective catheterization with a 6F ureteric catheter. The main surgical procedure will be flexible ureteroscopy, performed according to the surgeon's standard technique, without special maneuvers like stone displacement. For patients with large stone burdens, an access sheath will be used to facilitate efficient stone removal. Stone characteristics, including size, location, and renal anatomy, will be recorded for analysis.
At the end of the procedure, an endoscopic examination of the pelvicalyceal system will be performed to assess stone fragmentation and the presence of residual fragments or dust. This examination will be video-recorded for post-operative assessment. The primary outcome of the study will be the comparison of stone free rate between the two positioning groups, while secondary outcomes will include the evaluation of perioperative complications, operative time, postoperative pain, hospital stay, and cost analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard group | Other | Procedure: standard lithotomy positionPatients will be placed in regular lithotomy position with operating table at 0 degrees of tilting. |
| T-tilted group | Experimental | Procedure: T-tilting of the patient during surgeryPatients will be placed at the T-Tilt position (15 degrees Trendelenburg and 15 degrees away from the surgical side kidney). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients above the age of 16 years of either sex who did not have a pre-existing ureteral stent presented to the Urology clinic in our university hospitals with kidney stones with size up to 2.5cm (estimated by CTUT as the greatest dimension or the summation of the greatest dimensions).
Key exclusion criteria (4 listed)
- Previous open renal surgery or renal trauma.
- Patients with renal anomalies.
- Patients with untreated or active UTI.
- Patients who suffer from medical conditions that preclude the application of Trendelenburg position (lung disease, congestive heart failure).
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 |
|---|---|---|
| T-tilting of the patient during surgeryPatients will be placed at the T-Tilt position (15 degrees Trendelenburg and 15 degrees away from the surgical side kidney) during surgery. | Procedure or surgery | T-tilted group |
| standard lithotomy positionPatients will be placed in regular lithotomy position with operating table at 0 degrees of tilting. | Procedure or surgery | standard group |
Primary outcome
stone free rate in the T-tilted position during surgery
Time frame: the duration of the study of at least 6 months
Follow up visits will be scheduled after 2 weeks; computed tomography urinary tract (CTUT) will be performed to identify stone-free rates and the procedure will be considered successful if no stones can be identified >4mm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 37205217Yuan Y, Liang YN, Li KF, Ho YR, Wu QL, Zhao Z. A meta-analysis: retrograde intrarenal surgery vs. percutaneous nephrolithotomy in children. Front Pediatr. 2023 May 2;11:1086345. doi: 10.3389/fped.2023.1086345. eCollection 2023.
- Background: PubMed 34251886Liaw CW, Khusid JA, Gallante B, Bamberger JN, Atallah WM, Gupta M. The T-Tilt Position: A Novel Modified Patient Position to Improve Stone-Free Rates in Retrograde Intrarenal Surgery. J Urol. 2021 Nov;206(5):1232-1239. doi: 10.1097/JU.0000000000001948. Epub 2021 Jul 12.
- Background: PubMed 24824146Pan J, Xue W, Xia L, Zhong H, Zhu Y, Du Z, Chen Q, Huang Y. Ureteroscopic lithotripsy in Trendelenburg position for proximal ureteral calculi: a prospective, randomized, comparative study. Int Urol Nephrol. 2014 Oct;46(10):1895-901. doi: 10.1007/s11255-014-0732-z. Epub 2014 May 14.
- Background: PubMed 20629566Hyams ES, Munver R, Bird VG, Uberoi J, Shah O. Flexible ureterorenoscopy and holmium laser lithotripsy for the management of renal stone burdens that measure 2 to 3 cm: a multi-institutional experience. J Endourol. 2010 Oct;24(10):1583-8. doi: 10.1089/end.2009.0629.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-tilting of the patient during surgery and standard lithotomy position in people with Stone, Kidney, run by Ain Shams 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emad Tawfeik, MBBCH (+2001210235447, emadmamdouh676@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone free rate in the T-tilted position during surgery (time frame: the duration of the study of at least 6 months). 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 NCT06860113, which also lists 4 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 17 Jul 2025.