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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03776370
Other study ID # 20181155
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date January 1, 2022

Study information

Verified date April 2022
Source Third Military Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date January 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Pathological biopsy confirmed adenocarcinoma of the rectum; 2. Preoperative assessment of tolerance to surgery without major organ dysfunction; 3. Patients must be able to understand and voluntarily sign written informed consent; 4. The surgical method is laparoscopic or robotic anterior rectal cancer resection. Exclusion Criteria: 1. The patient cannot tolerate the operation; 2. Refusal to sign informed consent; 3. Patients with distant metastasis of rectal cancer; 4. The surgical method was changed to miles or Hartman; 5. Unable to complete the follow - up

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Preserve the left colonic artery
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.

Locations

Country Name City State
China zongming,Kang Chongqing Chongqing
China zongming,Kang Yuzhong Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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- — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of postoperative anastomotic leakage was compared between the two groups. 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
Primary The distant metastasis rates of rectal cancer between the two groups were compared. The incidence of distant metastasis rectal cancer within two years after surgery was compared between the intervention group and the control group. Two years after surgery
Primary The local recurrence rates of rectal cancer between the two groups were compared. 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
Primary The five-year survival rates of rectal cancer between the two groups were compared. The 5-year survival rates of rectal cancer in the intervention group and the control group were compared. Five years after surgery
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