- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03776370
Preserving Left Colonic Artery During Radical Resection of Rectal Cancer
April 28, 2022 updated by: Weidong Tong, Third Military Medical University
A Clinical Cohort Study on the Effect of Preserving Left Colonic Artery During Radical Resection of Rectal Cancer on Anastomotic Leakage and Oncology Efficacy
To evaluate the feasibility and clinical significance of preserving left colonic artery in rectal cancer surgery.The investigators will focus on the effect of preserving left colonic artery during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators performed three-dimensional (3D) reconstruction to investigate the vascular anatomy, including the inferior mesenteric artery (IMA) and left colic artery (LCA),to help make pre-operative strategies of rectal cancer surgery.The investigators will preserving the left colonic artery during rectal cancer surgery and evaluate its feasibility and clinical significance.The investigators will focus on the effect of preserving left colonic artery during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400000
- zongming,Kang
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Yuzhong, Chongqing, China, 400000
- zongming,Kang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who underwent laparoscopic or robotic anterior rectal resections carried out by two surgeons at Daping Hospital.
Description
Inclusion Criteria:
- Pathological biopsy confirmed adenocarcinoma of the rectum;
- Preoperative assessment of tolerance to surgery without major organ dysfunction;
- Patients must be able to understand and voluntarily sign written informed consent;
- The surgical method is laparoscopic or robotic anterior rectal cancer resection.
Exclusion Criteria:
- The patient cannot tolerate the operation;
- Refusal to sign informed consent;
- Patients with distant metastasis of rectal cancer;
- The surgical method was changed to miles or Hartman;
- Unable to complete the follow - up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Preserve the left colonic artery
Preservation of left colonic artery in rectal cancer surgery.
|
Preservation of left colonic artery in rectal cancer surgery.
|
|
The left colonic artery is not preserved
The left colonic artery was dissected in rectal cancer surgery
|
The left colonic artery was dissected in rectal cancer surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The incidence of postoperative anastomotic leakage was compared between the two groups.
Time Frame: Within 30 days after surgery
|
The incidence of anastomotic leakage within 30 days after surgery was compared between the intervention group and the control group.
|
Within 30 days after surgery
|
|
The distant metastasis rates of rectal cancer between the two groups were compared.
Time Frame: Two years after surgery
|
The incidence of distant metastasis rectal cancer within two years after surgery was compared between the intervention group and the control group.
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Two years after surgery
|
|
The local recurrence rates of rectal cancer between the two groups were compared.
Time Frame: Two years after surgery
|
The incidence of local recurrence rectal cancer within two years after surgery was compared between the intervention group and the control group.
|
Two years after surgery
|
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The five-year survival rates of rectal cancer between the two groups were compared.
Time Frame: Five years after surgery
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The 5-year survival rates of rectal cancer in the intervention group and the control group were compared.
|
Five years after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wei d tong, PhD, Army Military Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fan YC, Ning FL, Zhang CD, Dai DQ. Preservation versus non-preservation of left colic artery in sigmoid and rectal cancer surgery: A meta-analysis. Int J Surg. 2018 Apr;52:269-277. doi: 10.1016/j.ijsu.2018.02.054. Epub 2018 Mar 1.
- Sekimoto M, Takemasa I, Mizushima T, Ikeda M, Yamamoto H, Doki Y, Mori M. Laparoscopic lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery. Surg Endosc. 2011 Mar;25(3):861-6. doi: 10.1007/s00464-010-1284-7. Epub 2010 Aug 20.
- Zheng H, Li F, Xie X, Zhao S, Huang B, Tong W. Preservation versus nonpreservation of the left colic artery in anterior resection for rectal cancer: a propensity score-matched analysis. BMC Surg. 2022 May 10;22(1):164. doi: 10.1186/s12893-022-01614-y.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2018
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
January 1, 2022
Study Registration Dates
First Submitted
December 9, 2018
First Submitted That Met QC Criteria
December 11, 2018
First Posted (Actual)
December 14, 2018
Study Record Updates
Last Update Posted (Actual)
May 4, 2022
Last Update Submitted That Met QC Criteria
April 28, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20181155
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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