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Patient Positioning for Treatment of Proximal Ureteral Stones

2026년 6월 2일 업데이트: Mantu Gupta, Icahn School of Medicine at Mount Sinai

Optimal Patient Positioning and Strategy for the Treatment of Proximal Ureteral Stones

Ureteroscopic management of proximal ureteral stones presents technical challenges including stone retropulsion, prolonged operative time, and conversion to intrarenal treatment. Reverse Trendelenburg positioning has been shown to reduce proximal stone migration and operative time in ureteral stones, while the T-tilt position improves intrarenal stone clearance. The optimal strategy for proximal ureteral stones (treating stones in situ using reverse Trendelenburg versus pushing stones into the kidney followed by intrarenal treatment in T-tilt) remains unknown.

This randomized controlled trial compares these two strategies, with primary focus on operative time as a measure of procedural efficiency.

A total of 54 patients (27 per arm) will be enrolled at Mount Sinai West.

연구 개요

상세 설명

Ureteroscopy has become a primary modality for the management of ureteral and renal calculi due to its high efficacy, minimally invasive nature, and favorable safety profile. Despite advances in flexible ureteroscopy, laser lithotripsy, and access technologies, proximal ureteral stones remain technically challenging, largely due to their tendency to migrate retrograde into the kidney, leading to prolonged operative time, increased need for flexible ureteroscopy, and lower procedural efficiency.

Stone retropulsion is influenced by laser energy, irrigation flow, ureteral anatomy, and gravitational forces. Several mechanical and laser-based strategies have been explored to mitigate migration, though results have been variable. Patient positioning represents a simple and cost-neutral intervention that may alter stone behavior intraoperatively without requiring additional devices.

Reverse Trendelenburg positioning has recently been shown to reduce proximal stone migration and improve operative efficiency during ureteroscopic treatment of ureteral stones. In a randomized controlled trial, patients positioned in reverse Trendelenburg experienced lower rates of retropulsion, reduced need for conversion to flexible ureteroscopy, and shorter operative times compared with standard positioning. However, this study included stones across multiple ureteral segments and did not focus specifically on proximal ureteral stones, which may have distinct anatomical and migration characteristics.

Conversely, T-tilt positioning has been investigated in the context of intrarenal stone treatment. Prior randomized evidence demonstrated that T-tilt positioning during retrograde intrarenal surgery resulted in higher stone-free rates, likely due to improved gravitational alignment of calyces and enhanced fragment clearance. These findings suggest that positioning may also optimize intrarenal lithotripsy efficiency once stones migrate into the kidney.

For proximal ureteral stones, two competing operative strategies are commonly used in clinical practice: (1) in situ ureteral treatment with efforts to prevent migration, potentially optimized by reverse Trendelenburg positioning, or (2) intentional pushback of the stone into the kidney followed by intrarenal lithotripsy under positioning conditions favorable for fragment clearance, such as T-tilt.

The decision to use one strategy over another is based on surgeon preference. Currently, there are no guidelines or standards favoring either approach. To date, no randomized study has directly compared these two positioning-based strategies for proximal ureteral stones. Given that operative time is strongly associated with anesthesia exposure, procedural cost, complication risk, and resource utilization, it represents a clinically meaningful and objective primary endpoint to evaluate procedural efficiency between approaches.

This study seeks to address an important gap in endourologic practice by determining the optimal positioning strategy for proximal ureteral stone management, with the goal of improving operative efficiency, reducing procedural burden, and informing evidence-based surgical decision-making.

연구 유형

중재적

등록 (추정된)

54

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • New York
      • New York, New York, 미국, 10019

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion criteria:

  • Adults aged 18 years and older.
  • Diagnosed with kidney stones and scheduled for fURS.
  • Stone burden > 1 cm and/or multiple stones will be eligible.
  • Able and willing to provide informed consent.

Exclusion criteria:

  • Pregnant persons as determined by pre-operative urine pregnancy test (standard of care at the institution)
  • Untreated UTI
  • Patients with urinary anomalies (e.g., urinary diversion, ureteral reconstruction, horseshoe kidney)
  • Single stone < 1 cm

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Reverse Trendelenburg Position
Participants undergo ureteroscopic lithotripsy in reverse Trendelenburg positioning with attempted in situ treatment of the proximal ureteral stone to minimize proximal migration.
Patients will be positioned in reverse Trendelenburg at a 20 degree incline with the use of a digital protractor. Lithotripsy will be performed within the ureter with attempts to prevent proximal migration and until all fragments are removed.
활성 비교기: T-Tilt Position
Participants undergo intentional relocation of the proximal ureteral stone into the kidney followed by intrarenal lithotripsy performed in the T-tilt position.
Stone will be intentionally relocated into the kidney when feasible, followed by intrarenal lithotripsy in T-tilt position. In the T-tilt position the table is angled 15-degree Trendelenburg and 15-degree airplane away from the surgical side kidney with the use of a digital protractor. This allows fragments to rest in a superior and medial position away from the lower pole to facilitate removal.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Total operative time
기간: Immediately postoperatively on the day of surgery
Operative time will be used to compare procedural efficiency
Immediately postoperatively on the day of surgery

2차 결과 측정

결과 측정
측정값 설명
기간
Proportion of participants stone-free
기간: From Week 4 to Week 6 postoperatively
Proportion of participants without residual stone fragments on postoperative CT imaging
From Week 4 to Week 6 postoperatively
Proportion of procedures requiring additional equipment or procedural maneuvers
기간: Immediately after completion of surgery on the day of procedure
Proportion of procedures requiring additional equipment or procedural maneuvers beyond the initially planned operative strategy to complete stone treatment
Immediately after completion of surgery on the day of procedure
Proportion of strategy failure
기간: Assessed immediately at completion of surgery on the day of procedure
Proportion of cases in which the randomized operative strategy could not be successfully executed intraoperatively
Assessed immediately at completion of surgery on the day of procedure
Incidence of Complications
기간: Through postoperative day 30
Incidence of postoperative complications, defined as any Clavien-Dindo complications, emergency department visits, or readmission related to the procedure. Outcome is recorded as the occurrence of a complication event (yes or no). Each participant is counted once, and the outcome is recorded as a binary variable indicating whether any of these events occurred or did not occur.
Through postoperative day 30

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Mantu Gupta, MD, Icahn School of Medicine at Mount Sinai

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 21일

기본 완료 (추정된)

2027년 11월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2026년 5월 14일

QC 기준을 충족하는 최초 제출

2026년 5월 20일

처음 게시됨 (실제)

2026년 5월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 2일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

protecting participant privacy/confidentiality

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Reverse Trendelenburg Position에 대한 임상 시험

구독하다