Clinical Value of Left Colic Artery in Laparoscopic Radical Rectectomy

Not Applicable

• Conditions: Overall Survival; Postoperative Complications
• Interventions: Procedure: LCA-nP; Procedure: LCA-P

• Registration Number: NCT03349788
• Lead Sponsor: Shanghai Minimally Invasive Surgery Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-19
• Study First Posted: 2017-11-22
• Last Update Submitted: 2017-12-02
• Last Update Posted: 2017-12-05
• Study Start: 2018-01-01
• Primary Completion: 2021-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 354

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LCA-nP	LCA-nP	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.
LCA-P	LCA-P	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.

Primary Outcome Measures

Name	Time	Method
Disease-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
3 years overall survival	3 years
The rate of LN.253 metastasis	2 weeks
The rate of local and distant recurrence	3 years
The rate of postoperative coml[ications and mortality	30 days

Trial Locations

Locations (1)

Shanghai Ruijin Hospttal; 🇨🇳 Shanghai, Sahgnhai, China