- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07643454
Comparison of Trans-Stomial Bladder Lithotripsy Using Mini-Percutaneous Equipment Versus Trans-stomial Bladder Lithotripsy Using Flexible Fibroscope, Percutaneous Approach and Open Cystolithotomy in Patients With Continent Catheterizable Urinary Reservoir (Mini-DUCC)
The urological management of neurological patients is crucial to ensure patient survival and improve their quality of life. The natural progression of disease in central neurological bladders typically involves a major decrease in both bladder capacity and contractile function, often necessitating cystectomy. One alternative to urinary reconstruction is continent catheterizable urinary diversion (e.g., Miami pouch, Mitrofanoff, Monti, etc.). A common complication of these diversions is the formation of intravesical stones, which require surgical management. When the urethra allows access to the urinary diversion, the gold standard is transurethral lithotripsy using a cystoscope; however, when this is not feasible, several techniques exist, albeit without clear recommendations.
In the literature, the most frequently discussed techniques include bladder dilation, percutaneous bladder lithotripsy using nephrolithotripsy (NLPC) equipment, and trans-stomal lithotripsy using a flexible fibroscope. Although bladder dilation has shown higher complication rates in case series compared to other techniques, there is very little comparative data between the percutaneous and trans-stomal methods in the literature. Case series indicate a higher risk of fistula formation with the percutaneous technique for urinary diversions performed in the gastrointestinal tract as compared to native bladder diversions, and a risk of stenosis or loss of continence with the trans-stomal technique.
At the Hospices Civils de Lyon (HCL), the Urology Department of the Lyon Sud Hospital has expertise in neuro-urology with a large cohort of patients presenting continent catheterizable urinary diversions, and the Urology Department of Edouard Herriot Hopspital has expertise in NLPC, particularly with the use of mini-NLPC (smaller nephroscope diameter). The synergy between these two departments has enabled the creation of a large cohort, with frequent use of the percutaneous route for bladder lithotripsy and, since 2020, the trans-stomal route using mini-NLPC equipment.
Therefore, given the limited data available in the literature, this retrospective comparative study would provide stronger evidence to improve the management of these patients.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Nadia ABID, MD, PhD
- 전화번호: +33 4 72 11 96 75
- 이메일: nadia.abid@chu-lyon.fr
연구 연락처 백업
- 이름: Léonard TOTARO, MD
- 전화번호: +33 613230009
- 이메일: leonard.totaro@chu-lyon.fr
연구 장소
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Lyon, 프랑스, 69003
- Hôpital Edouard Herriot
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연락하다:
- Nadia ABID, MD, PhD
- 전화번호: +33 4 72 11 96 75
- 이메일: nadia.abid@chu-lyon.fr
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Pierre-Bénite, 프랑스, 69495
- Hôpital Lyon Sud
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연락하다:
- Théo ARBER, MD, PhD
- 전화번호: +33 472678813
- 이메일: theo.arber@chu-lyon.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adult patient (aged 18 years or older)
- Patient with a catheterizable continent urinary diversion
- History of surgical intervention via vesicolithotomy, percutaneous cystolitholapaxy, trans-stomal cystolitholapaxy, or flexible endoscopic laser cystolithotripsy via the continent stoma between 01/01/2015 and 31/12/2024
- Patient has expressed non-opposition to participate in the research
Exclusion Criteria:
- Percutaneous or trans-stomal surgery for foreign body removal
- Postoperative follow-up period of less than 1 month after lithotripsy (Except for Clavien-Dindo Grade V cases)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment
Patient operated on using Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment
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Patients of all groups will answer this quality of life questionnaire that has been specially designed for the study
Patients of all groups will answer this validated quality of life questionnaire
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Trans-stomial bladder lithotripsy using flexible fibroscope
Patient operated on using Trans-stomial bladder lithotripsy using flexible fibroscope
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Patients of all groups will answer this quality of life questionnaire that has been specially designed for the study
Patients of all groups will answer this validated quality of life questionnaire
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Percutaneous cystholithotripsy
Patient operated on using Percutaneous cystholithotripsy
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Patients of all groups will answer this quality of life questionnaire that has been specially designed for the study
Patients of all groups will answer this validated quality of life questionnaire
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Open Cystolithotomy
Patient operated on using Open Cystolithotomy
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Patients of all groups will answer this quality of life questionnaire that has been specially designed for the study
Patients of all groups will answer this validated quality of life questionnaire
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Residual stone size greater than 4mm postoperatively.
기간: Up to 7 days after surgery
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Residual stone size greater than 4mm postoperatively will be investigated on imaging control
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Up to 7 days after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Qol-DUCC questionnaire answers
기간: At inclusion
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answers to the Qol-DUCC questionnaire will be analysed to assess patient quality of life
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At inclusion
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Qualiveen questionnaire score
기간: At inclusion
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The Qualiveen questionnaire score will be analysed to assess patient quality of life
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At inclusion
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공동 작업자 및 조사자
수사관
- 수석 연구원: Nadia ABID, MD, PhD, Hospices Civils de Lyon
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 69HCL26_0256
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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