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Anatomical Classifications of Inferior Mesenteric Artery (IMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515850
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Li Chuan, Southwest Hospital, China

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

Condition or disease
Colorectal Cancer

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Trial of Anatomical Classifications of Inferior Mesenteric Artery in Laparoscopic Rectal Resection Surgery
Actual Study Start Date : January 5, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : January 30, 2021



Primary Outcome Measures :
  1. classifications vascular branches of IMA [ Time Frame: 3years ]
    based on the positon of LCA that conjoin the IMA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  1. Patients who undergoing laparoscopic rectal cancer surgery.
  2. Pathology: adenocarcinoma or huge adenomas proven by colonoscopic biopsy.
  3. Localization: tumor located between distal sigmoid colon and anal canal.
  4. Patients have to be aware of the aim of the trial, and have signed the informed consent.

Exclusion Criteria:

  1. History of any gastrointestinal surgery.
  2. Patients with emergent surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515850


Contacts
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Contact: Tang Bo, M.D +862368754167 tangtbo@sina.com
Contact: Li Chuan, M.D +86-18323479228 yupeiwu1961@aliyun.com

Locations
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China
General Surgery Center of PLA Recruiting
Chongqing, China, 400038
Contact: Yu Peiwu, M.D/Ph.D    +862368754167    yupeiwu01@sina.com   
Sponsors and Collaborators
Li Chuan

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Responsible Party: Li Chuan, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT03515850    
Other Study ID Numbers: Southwest-IMA-rectal
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases