- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03019016
Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
A Multi-Center Retrospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
The primary objective of this study is to retrospectively compare the perioperative and short-term (discharge through 30 days) outcomes of intracorporeal and extracorporeal anastomosis in minimally invasive right colectomies for benign and malignant disease.
The secondary objective of this study is to retrospectively compare the rates of incisional hernia (up to 6 month post procedure) between intracorporeal and extracorporeal arms.
연구 개요
상세 설명
This is a multi-center, retrospective chart review study of all consecutive cases of right colectomy performed by participating surgeons at their respective institutions that meet all inclusion and exclusion criteria. All cases of right colectomy performed with intracorporeal or extracorporeal anastomoses or via laparoscopic or robotic platforms that meet the study inclusion and exclusion criteria, will be considered for inclusion. The chart review will be performed in a reverse chronological order starting at a minimum of 30 days prior to IRB approval of the study at the site until the number of robotic-assisted and laparoscopic cases to be included per surgeon has been met. Study initiation at the participating site will occur once a research agreement has been executed between Intuitive Surgical and the participating Institution/Investigator and IRB approval has been obtained.
It is anticipated that the retrospective chart review will span the period between January 1, 2010 through 30-days prior to IRB approval of the study in 2016. Baseline patient characteristics, perioperative and post-operative short term clinical and pathological outcomes, and incisional hernia data will be obtained from hospital records for a total of up to approximately 1000 robotic and laparoscopic cases, among the 4 subgroups: robotic-assisted right colectomy with intracorporeal anastomosis (RRCIA), robotic-assisted right colectomy with extracorporeal anastomosis (RRCEA), laparoscopic right colectomy with intracorporeal anastomosis (LRCIA) and laparoscopic right colectomy with extracorporeal anastomosis (RRCEA). Since the data will have been de-identified, and is archival in nature, there will be no active subject recruitment.
연구 유형
등록 (예상)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age ≥ 18 years
- Patients with benign or malignant right colon disease
- Patients who have undergone robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to mid-transverse colon
Exclusion Criteria:
- Patients with perforated, obstructing or locally invasive neoplasm (T4b)
- Emergency procedures
- Patients undergoing right colectomy as a secondary procedure
- Patients undergoing radiation therapy for malignant neoplasia before and after procedure
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Robotic RC (IA)
Benign or malignant disease under going a right colectomy.
|
Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
|
|
Robotic RC (EA)
Patients with benign or malignant disease under going a right colectomy.
|
Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
|
|
Laparoscopic RC (IA)
Patients with benign or malignant disease under going a right colectomy.
|
Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
|
|
Laparoscopic RC (EA)
Patients with benign or malignant disease under going a right colectomy.
|
Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Chart review on PeriOperative Information
기간: Intraoperative through 30-days follow-up
|
Number of complications observed intraoperatively through 30-days
|
Intraoperative through 30-days follow-up
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Chart review on Postoperative Information
기간: Postoperative through 6 month follow-up
|
Number of complications observed postoperatively through 6 month
|
Postoperative through 6 month follow-up
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Shilpa Mehendale, Sr Director, Clinical Affairs, Intuitive Surgical, Inc.
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 (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. .
크론병에 대한 임상 시험
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L2 Bio, LLCFDAMap; Akan Biosciences, Inc.아직 모집하지 않음Crohn & amp;#39; s | Crohn & amp;#39; s Disease (CD)
-
Vanderbilt University Medical CenterTakeda Pharmaceuticals U.S.A., Inc.모집하지 않고 적극적으로염증성 장질환(IBD) | 궤양성 대장염(UC) | Crohn & amp;#39; s Disease (CD)미국
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Azienda Ospedaliera Ordine Mauriziano di Torino완전한
-
Region SkaneLund University; Linkoeping University; Malmö University모병
-
Nova Scotia Health Authority아직 모집하지 않음
-
Shanghai 10th People's Hospital모집하지 않고 적극적으로분변 미생물 이식 | 염증성 장 질환 (Crohn & amp;#39; s 질병 및 궤양 성 대장염)중국
-
Raincy Montfermeil Hospital GroupJanssen Cilag S.A.S.모병염증성 장질환(IBD) | 염증성 장 질환 (Crohn & amp;#39; s 질병 및 궤양 성 대장염)프랑스
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Kaohsiung Medical University아직 모집하지 않음폐 선암종 | 폐암(진단) | Condition/Disease
Right Colectomy에 대한 임상 시험
-
Brown UniversityNational Institute on Aging (NIA)완전한
-
Jena University HospitalThe German Heart Foundation알려지지 않은
-
Medical Research Council, South AfricaAga Khan University; Texas Woman's University알려지지 않은
-
The George InstituteNational Health and Medical Research Council, Australia; Medical University of South Carolina 그리고 다른 협력자들완전한
-
Brigham and Women's HospitalBeth Israel Deaconess Medical Center완전한