Anatomical Classifications of Inferior Mesenteric Artery (IMA)
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| ClinicalTrials.gov Identifier: NCT03515850 |
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Recruitment Status :
Recruiting
First Posted : May 4, 2018
Last Update Posted : May 4, 2018
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Sponsor:
Li Chuan
Information provided by (Responsible Party):
Li Chuan, Southwest Hospital, China
| Tracking Information | |||||||||
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| First Submitted Date | April 23, 2018 | ||||||||
| First Posted Date | May 4, 2018 | ||||||||
| Last Update Posted Date | May 4, 2018 | ||||||||
| Actual Study Start Date | January 5, 2018 | ||||||||
| Estimated Primary Completion Date | July 1, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
classifications vascular branches of IMA [ Time Frame: 3years ] based on the positon of LCA that conjoin the IMA
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Anatomical Classifications of Inferior Mesenteric Artery | ||||||||
| Official Title | Clinical Trial of Anatomical Classifications of Inferior Mesenteric Artery in Laparoscopic Rectal Resection Surgery | ||||||||
| Brief Summary | The vascular branches of inferior mesenteric artery (IMA) involve superior rectal artery(SRA),Sigmoid artery(SA) and the left colic artery(LCA). Different levels of ligation of the (IMA) are applied in rectal cancer surgery, including retain or not retain the left colic artery(LCA). Retained the LCA would facilitate the vascularity. The variations of vessels are more frequent in the combinations of branches, while LCA, SA and SRA may vary from people to people. Which contribute to the difficulty of surgery to retain the LCA.. As a result, a better understanding of the anatomical branches classification of IMA is a must during operation. However, existing studies of IMA's branches combination are very rare and often single-centered with minimal samples. In order to achieve better surgical outcome and reduce operative complications, the investigators design this study to investigate the anatomical classification of IMA and the surgical outcome of each type | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | This study is a prospective study，and based on the conjoin classifications of branches, the anticipant populations of this study is 500. | ||||||||
| Condition | Colorectal Cancer | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
500 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | January 30, 2021 | ||||||||
| Estimated Primary Completion Date | July 1, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03515850 | ||||||||
| Other Study ID Numbers | Southwest-IMA-rectal | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Li Chuan, Southwest Hospital, China | ||||||||
| Study Sponsor | Li Chuan | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Southwest Hospital, China | ||||||||
| Verification Date | April 2018 | ||||||||