- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03328000
Radiological Re-evaluation of Failed Anastomotic Uretheroplasty for PFUDDI Using Computed Tomographic Urethrography.
Radiological Re-evaluation of Failed Anastomotic Uretheroplasty for PFUDDI Using Computed Tomographic Urethrography
연구 개요
상세 설명
Blunt pelvic trauma results in posterior urethral distraction defects (PUDDs) in ª10% of cases; such injury commonly involves the membranous urethra at the point of departure from the bulbospongiosum, at the prostatomembranous junction, or at any point between its departure and the apex of the prostate [1]. PUDDs are complex pathologically, involving displacement and misalignment of the severed urethral ends with intervening and surrounding fibrosis. Detached bony fragments and callus formation add to the pathological complexity. For a successful repair of a PUDD it is necessary to identify the specific anatomy of the distraction defect before undertaking any treatment[2].
Currently most PFUDDI are associated with trauma as an etiology. Posterior urethral disruption occurs in 4-14% of pelvic ring fractures and 80-90% of posterior urethral injuries are associated with pelvic fractures[4]. Sixty-five percent of post-traumatic posterior urethral injuries are complete[5]. Following trauma the ruptured urethra is usually replaced by fibrosis and in between there is no lumen. Anastomotic urethroplasty is a well established procedure to deal with posterior urethral strictures and gives very good long-term results[6,7].
The success rate of repeat surgery for failed urethroplasty is reported to be less than that for primary urethroplasty. Jakse et al;reported a 71% failure rate following end-to-end urethroplasty with a history of prior urethroplasty[8].
The success rate of end-to-end anastomosis varies from 77 to 95% as described by different series[9,10,11,12]There are very few reports regarding urethroplasty for previously failed PFUDDI[13,14],The most common causes of failure of urethroplasty are the inadequate excision of the strictured segment and surrounding fibrosis, improper case selection and ischemia[14].
For a successful repair of a PFUDDI it is necessary to identify the specific anatomy of the distraction defect before undertaking any treatment, The classic approach for evaluating a PFUDDI is through Retrograde Urethrography [RUG] and Voiding cysto-urethrography (VCUG), particularly while the patient is attempting to void. However, this study can often give a false interpretation of the exact anatomy of the distraction defect on many occasions[15].
It often cannot provide an accurate determination of the defect length because of poor prostatic urethral filling and it provides little information on the extent of corpus spongiosal fibrosis or prostatic displacement[15].
CTCUG was more informative than conventional radiology in several aspects; the location and the length of the distraction defect; the direction of alignment or misalignment; the bone anatomy (ectopic fragments, callus); and the presence of additional urinary pathology (fistulae, false passages, diverticulae)[2].
연구 유형
등록 (예상)
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 1-patient with normal bladder. 2-Patient with fructure pelvis.
Exclusion Criteria:
- 1-Patient without fracture pelvis. 2-Patient with other pathology as neurogenic bladder.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Evaluation of failed anastomotic urethroplasty for pelvic fracture urethral distraction defect injury[PFUDDI], Measurement of the actual length and location of the defect.and detection of bony abnormality as fragment affecting the healing process.
기간: 2years
|
Patient with failed anastmotic urethroplasty will undergo CTU to show if they will provide more data about the anatomy of the defect including lenth degree of the fibrosis pelvic blood supply and presence of bone defect affecting healing or any other finding can not be evaluated by other diagnostic measures.
|
2years
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
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
기타 연구 ID 번호
- failed urethroplasty
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. .