Evaluation of Retrograde Intra Renal Surgery in the T-tilted Position

NCT06860113 | Recruiting

• 1 other identifier: RIRS in T-tilted position
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Stone, Kidney

Keywords

stone free rate, suction sheath

Outcome Measures

Primary Outcomes (1)

• 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.

  the duration of the study of at least 6 months

Study Arms (2)

standard group

OTHER

Patients will be placed in regular lithotomy position with operating table at 0 degrees of tilting.

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).

Procedure: T-tilting of the patient during surgery

Interventions

T-tilting of the patient during surgery PROCEDURE

Patients will be placed at the T-Tilt position (15 degrees Trendelenburg and 15 degrees away from the surgical side kidney) during surgery.

T-tilted group

standard lithotomy position PROCEDURE

Patients will be placed in regular lithotomy position with operating table at 0 degrees of tilting.

standard group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinShams university hospitals

Cairo, Abbassia, Cairo, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 37205217 BACKGROUND

• Liaw 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.

  PMID: 34251886 BACKGROUND

• Pan 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.

  PMID: 24824146 BACKGROUND

• Hyams 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.

  PMID: 20629566 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Emad Tawfeik, MBBCH

CONTACT

+2001210235447; emadmamdouh676@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 5, 2025
• Study Start: March 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

EG (1)