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Clinical Value of Left Colic Artery in Laparoscopic Radical Rectectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03349788
Recruitment Status : Unknown
Verified November 2017 by Shanghai Minimally Invasive Surgery Center.
Recruitment status was:  Not yet recruiting
First Posted : November 22, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai Minimally Invasive Surgery Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Overall Survival Postoperative Complications Procedure: LCA-nP Procedure: LCA-P Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial: Clinical Value of Preserving Left Colic Artery in Laparoscopic Radical Rectectomy
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Procedure: LCA-nP
The group underwent lapaoroscopic radical rectectomy without preserving left colic artery.
Active Comparator: 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.
 Procedure: LCA-P
The group underwent lapaoroscopic radical rectectomy with preserving left colic artery.


Outcome Measures
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Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. The rate of postoperative coml[ications and mortality [ Time Frame: 30 days ]
  2. 3 years overall survival [ Time Frame: 3 years ]
  3. The rate of local and distant recurrence [ Time Frame: 3 years ]
  4. The rate of LN.253 metastasis [ Time Frame: 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349788


Contacts
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Contact: Minhua Zheng, PhD +86-13564119545 zmhtiger@yeah.net
Contact: Hiju Hong, PhD Student +86-13564119545 jing12722@naver.com

Locations
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China, Sahgnhai
Shanghai Ruijin Hospttal
Shanghai, Sahgnhai, China, 200000
Sponsors and Collaborators
Shanghai Minimally Invasive Surgery Center
Investigators
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Study Director: Minhua Zheng, PhD Ruijin Hospital
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Shanghai Minimally Invasive Surgery Center
ClinicalTrials.gov Identifier: NCT03349788    
Other Study ID Numbers: ShanghaiMISC-LCA
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Minimally Invasive Surgery Center:
Left colic artery
Laparoscopic Surgery
Anterior resection of rectum
Rectum cancer
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes