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

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
      • 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:

  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 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.
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
The five-year survival rates of rectal cancer between the two groups were compared.
Time Frame: Five years after surgery
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.

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

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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