Clinical Value of Left Colic Artery in Laparoscopic Radical Rectectomy

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial: Clinical Value of Preserving Left Colic Artery in Laparoscopic Radical Rectectomy

Conditions
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Overall Survival, Postoperative Complications

Intervention / Treatment
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* Procedure: LCA-nP
* Procedure: LCA-P


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCA-nP<br>The group underwent laparoscopic radical rectectomy without preserving left colic artery. In IMA group, the dissecting based on TME is performed without preserving left colic artery. Surgeon should dissect the lymph nodes and ligated the vessel in the root of inferior mesenteric artery. | Procedure: LCA-nP<br>* The group underwent lapaoroscopic radical rectectomy without preserving left colic artery.<br>|
| Active Comparator: LCA-P<br>The group underwent laparoscopic radical rectectomy with preserving left colic artery. In LCA group, the dissecting based on TME is performed with preserving left colic artery. The relationship of inferior mesenteric artery, inferior mesenteric vein and LCA should be identified and ligated separately without LCA. | Procedure: LCA-P<br>* The group underwent lapaoroscopic radical rectectomy with preserving left colic artery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of postoperative coml[ications and mortality |  | 30 days | 
| 3 years overall survival |  | 3 years | 
| The rate of local and distant recurrence |  | 3 years | 
| The rate of LN.253 metastasis |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left colic artery, Laparoscopic Surgery, Anterior resection of rectum, Rectum cancer