Observatory of the Quality of Surgical Procedures for Digestive Cancers (Obchir)
Observatory of the Quality of Surgical Procedures for Digestive Cancers: Pilot Project.
Surgery for digestive cancers is managed according to quality standards, validated by the scientific community. Despite the diffusion of these standards through the benchmarks of good practice, the results of the surgery remain disparate.
In many countries, this "inequality of opportunity" has justified the establishment of quality assurance systems to measure the results of surgery for one or more localizations of digestive cancer.
These surgical audit experiments have shown a positive, rapid and cost-effective impact on complication rates, recurrence rates and overall survival even in the absence of interventional measures. The data collected also helped to improve the management of subgroups of patients usually excluded from clinical trials.
In Morocco, the National Cancer Prevention and Control Plan provides for the establishment of a quality assurance system with the introduction of a system for monitoring and evaluating the care of patients. This pilot project is part of this framework, for the group of patients who are candidates for surgery for digestive cancers.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Oujda, 모로코
- Regional center of oncology, surgical department
-
Rabat, 모로코, 10100
- Ibn Sina Hospital, Surgical department A
-
Rabat, 모로코, 10100
- Ibn Sina Hospital, Surgical department C
-
-
Please Enter The State Or Province
-
Rabat, Please Enter The State Or Province, 모로코, 10100
- National Institut of Oncology, Surgical oncology department
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- patients operated for a digestive cancer, proven or suspected, in a curative or palliative intent In elective situation: inclusion from surgery programming In emergent situation: inclusion no later than 72 hours after surgery
- Cancer proven or suspected in the following digestive tract: colon, appendix, anus, rectum, esophagus, stomach, eso-gastric junction, bile ducts, ampulla of Vater , pancreas, duodenum, small intestine and liver.
- Patient willing and able to agree to participate in the study
Exclusion Criteria:
Patient whose surgical intervention is indicated for:
- a condition that is not a digestive tract cancer, including whether retrospectively surgical exploration and / or histological examination reveals digestive localization cancer
- proven or suspected cancer of non-digestive location
- a proven or suspected cancer of peritoneal localization
- Patient whose surgical intervention is indicated for a progressive disease or a local recurrence proven or suspected of a digestive localization cancer having already been the resected (with the exception of situations of iterative liver resection for liver metastasis hepatic and recovery of the tumor bed after the discovery of vesicular cancer on cholecystectomy specimen)
- Patients whose intervention is for diagnostic purposes without any curative or palliative intention
- Patients whose surgery is a liver transplant
- Patients whose surgical intervention is local destruction (radiofrequency, microwaves) exclusively by percutaneous approach (without laparotomy or laparoscopy)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
90-day Mortality rate
기간: 90 days from surgery
|
Death within 90 days of surgical procedure
|
90 days from surgery
|
|
90-day Complication rate
기간: 90 days from surgery
|
Defined with by Clavien-Dindo grade I to IV within90 days of surgical procedure
|
90 days from surgery
|
|
3-year Overall survival
기간: from the date of operation to date of death from any cause, whichever came first, assessed up to 3 year
|
Overall survival is defined as time from initiation to death of any cause within 3years of surgical procedure
|
from the date of operation to date of death from any cause, whichever came first, assessed up to 3 year
|
|
3-year disease free survival
기간: from operation until recurrence of tumor or death from any cause, whichever came first, assessed up to 3 years
|
Disease free survival is defined as time from initiation to death of any cause within 3years of surgical procedure
|
from operation until recurrence of tumor or death from any cause, whichever came first, assessed up to 3 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Treatment decisions made within multidisciplinary team meeting / tumour board
기간: Prior to surgery
|
For every localization
|
Prior to surgery
|
|
Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging
기간: Prior to surgery
|
For every localization
|
Prior to surgery
|
공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Amine Benkabbou, Pr, Moroccan Society of Surgery
- 수석 연구원: Raouf Mohsine, Pr, National institut of oncology
- 수석 연구원: Abdelmalek Hrora, Pr, Moroccan Society of Surgery
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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. .