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Clinical Value of Left Colic Artery in Laparoscopic Radical Rectectomy

NCT ID: NCT03349788

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-01-01

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.

Detailed Description

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Conditions

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Overall Survival Postoperative Complications

Keywords

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Left colic artery Laparoscopic Surgery Anterior resection of rectum Rectum cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

LCA-nP

Intervention Type PROCEDURE

The group underwent lapaoroscopic radical rectectomy without preserving left colic artery.

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.

Group Type ACTIVE_COMPARATOR

LCA-P

Intervention Type PROCEDURE

The group underwent lapaoroscopic radical rectectomy with preserving left colic artery.

Interventions

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LCA-nP

The group underwent lapaoroscopic radical rectectomy without preserving left colic artery.

Intervention Type PROCEDURE

LCA-P

The group underwent lapaoroscopic radical rectectomy with preserving left colic artery.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Minimally Invasive Surgery Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minhua Zheng, PhD

Role: STUDY_DIRECTOR

Ruijin Hospital

Locations

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Shanghai Ruijin Hospttal

Shanghai, Sahgnhai, China

Site Status

Countries

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China

Central Contacts

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Minhua Zheng, PhD

Role: CONTACT

Phone: +86-13564119545

Email: [email protected]

Hiju Hong, PhD Student

Role: CONTACT

Phone: +86-13564119545

Email: [email protected]

References

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Lange MM, Buunen M, van de Velde CJ, Lange JF. Level of arterial ligation in rectal cancer surgery: low tie preferred over high tie. A review. Dis Colon Rectum. 2008 Jul;51(7):1139-45. doi: 10.1007/s10350-008-9328-y. Epub 2008 May 16.

Reference Type BACKGROUND
PMID: 18483828 (View on PubMed)

Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

Reference Type RESULT
PMID: 25651787 (View on PubMed)

Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-1502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11.

Reference Type RESULT
PMID: 24225001 (View on PubMed)

Deijen CL, Velthuis S, Tsai A, Mavroveli S, de Lange-de Klerk ES, Sietses C, Tuynman JB, Lacy AM, Hanna GB, Bonjer HJ. COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer. Surg Endosc. 2016 Aug;30(8):3210-5. doi: 10.1007/s00464-015-4615-x. Epub 2015 Nov 4.

Reference Type RESULT
PMID: 26537907 (View on PubMed)

Uehara K, Yamamoto S, Fujita S, Akasu T, Moriya Y. Impact of upward lymph node dissection on survival rates in advanced lower rectal carcinoma. Dig Surg. 2007;24(5):375-81. doi: 10.1159/000107779. Epub 2007 Aug 4.

Reference Type RESULT
PMID: 17785983 (View on PubMed)

Cirocchi R, Trastulli S, Farinella E, Desiderio J, Vettoretto N, Parisi A, Boselli C, Noya G. High tie versus low tie of the inferior mesenteric artery in colorectal cancer: a RCT is needed. Surg Oncol. 2012 Sep;21(3):e111-23. doi: 10.1016/j.suronc.2012.04.004. Epub 2012 Jul 6.

Reference Type RESULT
PMID: 22770982 (View on PubMed)

Kim HJ, Kim CH, Lim SW, Huh JW, Kim YJ, Kim HR. An extended medial to lateral approach to mobilize the splenic flexure during laparoscopic low anterior resection. Colorectal Dis. 2013 Feb;15(2):e93-8. doi: 10.1111/codi.12056.

Reference Type RESULT
PMID: 23061515 (View on PubMed)

Mari G, Maggioni D, Costanzi A, Miranda A, Rigamonti L, Crippa J, Magistro C, Di Lernia S, Forgione A, Carnevali P, Nichelatti M, Carzaniga P, Valenti F, Rovagnati M, Berselli M, Cocozza E, Livraghi L, Origi M, Scandroglio I, Roscio F, De Luca A, Ferrari G, Pugliese R. "High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial" (HIGHLOW trial). Trials. 2015 Jan 27;16:21. doi: 10.1186/s13063-014-0537-5.

Reference Type RESULT
PMID: 25623323 (View on PubMed)

Titu LV, Tweedle E, Rooney PS. High tie of the inferior mesenteric artery in curative surgery for left colonic and rectal cancers: a systematic review. Dig Surg. 2008;25(2):148-57. doi: 10.1159/000128172. Epub 2008 Apr 29.

Reference Type RESULT
PMID: 18446037 (View on PubMed)

Other Identifiers

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ShanghaiMISC-LCA

Identifier Type: -

Identifier Source: org_study_id