Total Mesorectum Excision With Left Colic Artery Preservation for the Treatment of Rectal Cancer
A Randomized Controlled Clinical Trial to Investigate the Effects of Total Mesorectum Excision With Left Colic Artery Preservation for the Treatment of Rectal Cancer
1 other identifier
interventional
600
0 countries
N/A
Brief Summary
A randomized controlled clinical trial to compare the short and long term outcomes of left colic artery preservation for the treatment of Rectal Cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2018
CompletedFirst Posted
Study publicly available on registry
October 30, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedOctober 30, 2018
October 1, 2018
5 years
October 28, 2018
October 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anastomosis leakage rate
30 days
Secondary Outcomes (6)
Anastomosis bleeding rate
30 days
disease-free survival
5 years
local recurrence rate
5 years
operative time
1 day
number of lymph nodes retrieved
1 day
- +1 more secondary outcomes
Study Arms (2)
a high ligation of IMA
EXPERIMENTALtotal mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery
a low ligation of IMA
ACTIVE COMPARATORtotal mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery
Interventions
total mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery
total mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery
Eligibility Criteria
You may qualify if:
- Patients suitable for curative surgery over 18 years old;
- American Society of Anesthesiologists(ASA) grade I-III;
- Pathological diagnosis of rectal adenocarcinoma;
- Patients suitable for abdominalperineal resection
- Informed consent;
- No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
You may not qualify if:
- Pregnant patient;
- History of psychiatric disease;
- Use of systemic steroids;
- Simultaneous multiple primary colorectal cancer;
- Preoperative imaging examination results show:1. Tumor involves the surrounding organs and combined organ resection need to be done;2. distant metastasis;3. unable to perform R0 resection;
- History of any other malignant tumor in recent 5 years;
- Patients need emergency operation: mechanic ileus, perforation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yueming Sun, PhD
The First Affiliated Hospital with Nanjing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2018
First Posted
October 30, 2018
Study Start
January 1, 2019
Primary Completion
January 1, 2024
Study Completion
January 1, 2024
Last Updated
October 30, 2018
Record last verified: 2018-10