- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04198025
Psoas Density in Colorectal Cancer
Evaluating the Association Between Psoas Density Measurement on Preoperative CT Imaging and Postoperative Outcomes
Colorectal cancer (CRC) is the 3rd most common cancer worldwide. In the UK, CRC is the 4th most common cancer accounting for 12% of cancers diagnosed each year with approximately 41,300 new cases diagnosed in 2014. Surgery remains the only treatment option that can reliably achieve cure from colorectal cancer and thus nearly 20,000 major bowel resections are performed for this yearly in the UK. Surgery for these cancers however carries risk of major complications and potentially death. Selecting appropriate patients for surgery remains a challenge to cancer teams.
Risk factors exist for complications after surgery for CRC, many of which can be assessed and discussed with the patient prior to surgery, so that any decision to operate is with fully informed consent from the patient. Increasing attention is being paid to a patient's frailty or fitness as one of these risk factors. Our centre has previously shown that measuring the cross-sectional area of the psoas muscle (a large muscle near the spine) from preoperative imaging could predict major complications in colorectal cancer patients (Jones 2015), however specialist software and patient height is required to make this calculation. More recently we have demonstrated that the measurement of the psoas muscle density on preoperative imaging (i.e. routine CT scans that all patients have before surgery to plan treatment), may potentially be useful to predict which patients are at most risk of a major complication (Herrod 2019). If this finding holds true when tested on a larger scale, it could be used to help surgical teams make the decision on whether to offer surgical resection, what kind of operations to perform, how to best support individuals undergoing operation and to ensure that the patient has the most information available to decide what risk they are at by having major surgery.
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Derbyshire
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Derby, Derbyshire, 영국, DE22 3DT
- School of Graduate Entry Medicine, Royal Derby Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Patient criteria:
- Having a major colorectal resection for the treatment of cancer
- Elective or emergency surgery
- Adults, defined as age ≥18 years of age (no maximum limit)
- Had a preoperative CT scan of the abdomen with contrast (portal venous phase)
- Operation performed between 31st Aug 2013 - 31st Aug 2019
Exclusion Criteria:
- Not having a preoperative CT scan with contrast
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Patients who underwent colorectal resection
Patients in this observational study will have undergone CT scan as routine work up prior to resection of elective colorectal cancer. Psoas muscle density will be measured (in Hounsfield units from CT images) at lumbar vertebral level L3. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of post operative complications (Clavien-Dindo grade 3-4) during inpatient hospital stay.
기간: Through study completion, an average of 10 days.
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Recorded post operative complications requiring intervention during post operative stay until initial discharge from hospital.
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Through study completion, an average of 10 days.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Post operative length of stay
기간: Through study completion, usually between 6-10 days.
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Number of days
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Through study completion, usually between 6-10 days.
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Mortality
기간: Up to 5 year follow up from operation
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Recorded patient death
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Up to 5 year follow up from operation
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Post operative complications beyond hospital discharge.
기간: From hospital discharge to record review (i.e. 30 days, 90 days, 2 - 5 year follow up).
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Recorded post operative complications (including re-operation or recurrence) until discharge from surgical clinic or date of record review.
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From hospital discharge to record review (i.e. 30 days, 90 days, 2 - 5 year follow up).
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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 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. .