Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
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
 (submitted: April 23, 2018)
classifications vascular branches of IMA [ Time Frame: 3years ]
based on the positon of LCA that conjoin the IMA
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
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 23, 2018)
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:

  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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Tang Bo, M.D +862368754167 tangtbo@sina.com
Contact: Li Chuan, M.D +86-18323479228 yupeiwu1961@aliyun.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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