NCT03776370

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

3.1 years

First QC Date

December 9, 2018

Last Update Submit

April 28, 2022

Conditions

Keywords

rectal cancerPostoperative ComplicationsPreserve the left colonic artery

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Preserve the left colonic artery

Preservation of left colonic artery in rectal cancer surgery.

Procedure: Preserve the left colonic artery

The left colonic artery is not preserved

The left colonic artery was dissected in rectal cancer surgery

Procedure: The left colonic artery is not preserved

Interventions

Preservation of left colonic artery in rectal cancer surgery.

Preserve the left colonic artery

The left colonic artery was dissected in rectal cancer surgery.

The left colonic artery is not preserved

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent laparoscopic or robotic anterior rectal resections carried out by two surgeons at Daping Hospital.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

zongming,Kang

Chongqing, Chongqing Municipality, 400000, China

Location

zongming,Kang

Yuzhong, Chongqing Municipality, 400000, China

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Postoperative ComplicationsRectal Neoplasms

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Wei d tong, PhD

    Army Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 9, 2018

First Posted

December 14, 2018

Study Start

December 1, 2018

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

May 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations