Clinical trial NCT03349788: Clinical Value of Left Colic Artery in Laparoscopic Radical Rectectomy
Official title: Randomized Controlled Trial: Clinical Value of Preserving Left Colic Artery in Laparoscopic Radical Rectectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overall Survival
Postoperative Complications
Keywords: Left colic artery
Laparoscopic Surgery
Anterior resection of rectum
Rectum cancer
Lead sponsor: Shanghai Minimally Invasive Surgery Center
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Colorectal cancer is one of the most common tumors in Asia. According to the recent research, surgical procedure could provide more treatment benefit in rectal cancer. Therefore, it was consider that important to standardized and improved the surgical procedure for rectal cancer. With the development of anatomical technique, minimally surgery with laparoscopy had become the trend for surgical treatment. There were several studies has been done to evaluate the safety and feasibility of laparoscopic surgery. In order to achieve better surgical outcome and reduce operative complications, the investigators design stratified randomization, double blinded, muti - center clinical trail to investigate the value of left colic artery in laparoscopic radical rectectomy.


Eligibility criteria: Inclusion Criteria:

* Aged more then 18 years old;
* Diagnosed as rectal cancer with colonoscopic biopsy;
* Without metastasis;
* No Invasion of surrounding tissues;
* Limited operation;
* Underwent laparoscopic radical proctectomy(L-Dixon);
* BMI 18\~30kg/m2;
* Without multiple primary tumors;
* Sign on the Medical informed Consent.

Exclusion Criteria:

* Simultaneous or 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;
* Not suitable for laparoscopic surgery;
* Women during Pregnancy or breast feeding period;
* Informed consent refusal

Primary outcomes:
measure: Disease-free survival
timeFrame: 3 years
Secondary outcomes:
measure: The rate of postoperative coml[ications and mortality
timeFrame: 30 days
measure: 3 years overall survival
timeFrame: 3 years
measure: The rate of local and distant recurrence
timeFrame: 3 years
measure: The rate of LN.253 metastasis
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospttal
state: Sahgnhai
Study officials:
affiliation: Ruijin Hospital
name: Minhua Zheng, PhD
role: STUDY_DIRECTOR
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