- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01308489
Minimally Invasive Surgery in Treating Patients With Spinal Tumors
Comparison of Minimally Invasive Approaches of Spine Tumor Surgery
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. Length of operation (operating room [OR] time). II. Estimated blood loss (EBL). III. Complication rate. IV. Neurological preservation.
SECONDARY OBJECTIVES:
I. Motor strength and sensory level (neurological outcome). II. Bladder and bowel function. III. Post-operative pain. IV. Hospital length of stay (recovery time). V. Arthrodesis.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo posterior spinal tumor resection on day 0.
ARM II: Patients undergo anterior and posterior spinal tumor resection on day 0.
After completion of study treatment, patients are followed up for 6 months.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
California
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Duarte, California, 미국, 91010
- City of Hope Medical Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients must have a diagnosis of primary, secondary or metastatic spine tumor and be undergoing any posterior spinal fusion with or without anterior fusion anywhere from occiput to sacrum
- Greater than 3 month life expectancy
- Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
- Patients who are not surgical candidates for spine tumor removal, determined by the surgical team
- Patients who have undergone previous spine surgery for tumor removal will be excluded
- Patients with renal cell carcinoma
- As there is an emphasis on blood loss and length of surgery, the critical variable for homogeneity is the vascularity of the tumor; hypervascular spine tumors are regarded by surgeons as amongst the most challenging of cases; by far the three most common hypervascular metastatic tumors are those arising from renal cell carcinoma, thyroid carcinoma and melanoma; these pathologies are usually regarded as a distinct subset for this reason in the majority of studies; because we rarely encounter the later two pathologies in our practice, we chose to include only the former; however, to further homogenize our study population we will exclude all three of the known hypervascular metastatic spine tumors
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Arm I (posterior spinal tumor resection)
Patients undergo posterior spinal tumor resection on day 0.
|
보조 연구
다른 이름들:
Undergo posterior spinal tumor resection
Undergo anterior and posterior spinal tumor resection
|
|
실험적: Arm II (anterior and posterior spinal tumor resection)
Patients undergo anterior and posterior tumor resection on day 0.
|
보조 연구
다른 이름들:
Undergo posterior spinal tumor resection
Undergo anterior and posterior spinal tumor resection
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Estimated blood loss (EBL); in milliliters (ml)
기간: Day 0
|
Will be comparing means with the Wilcoxon test.
|
Day 0
|
|
Length of operation (OR time)
기간: Day 0
|
Will be comparing means with the Wilcoxon test.
|
Day 0
|
|
Complication rate
기간: Day 0
|
Day 0
|
|
|
Neurological preservation
기간: Post operation day 90
|
Post operation day 90
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Length of stay
기간: Less than 7 days
|
Less than 7 days
|
|
|
Pain symptoms
기간: Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
|
Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
|
|
|
Assessment of neurologic function using the ASIA (American Spinal Injury Association) Impairment Scale
기간: Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
|
This is an assessment of sensory and motor functions based upon the ASIA Impairment Scale
|
Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
|
|
Evaluation of arthrodesis
기간: Post-op day 1, 28, and 90
|
Plain x-ray films and CT scans are used to determine the success of arthrodesis (spinal fusion in this case) which is the artificial induction of joint ossification between two bones via surgery.
This is done to relieve intractable pain in a joint which cannot be managed by pain medication.
|
Post-op day 1, 28, and 90
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Rahul Jandial, MD, City of Hope Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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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