Clinical Value of Left Colic Artery in Laparoscopic Radical Rectectomy

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03349788
• Other study ID #: ShanghaiMISC-LCA
• Status: Not yet recruiting
• Phase: N/A
• First received: November 9, 2017
• Last updated: December 2, 2017
• Start date: January 1, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: November 2017
• Source: Shanghai Minimally Invasive Surgery Center
• Contact: Minhua Zheng, PhD
• Phone: +86-13564119545
• Email: zmhtiger[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 354
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Overall Survival
• Postoperative Complications

Intervention

Procedure:
• LCA-nP
The group underwent lapaoroscopic radical rectectomy without preserving left colic artery.
• LCA-P
The group underwent lapaoroscopic radical rectectomy with preserving left colic artery.

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospttal	Shanghai	Sahgnhai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Minimally Invasive Surgery Center

Country where clinical trial is conducted

China, 

References & Publications (9)

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. Review. — View Citation

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.2012.0 — View Citation

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 E — View Citation

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. — View Citation

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. Review. — View Citation

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 — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2007 Aug 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		3 years
Secondary	The rate of postoperative coml[ications and mortality		30 days
Secondary	3 years overall survival		3 years
Secondary	The rate of local and distant recurrence		3 years
Secondary	The rate of LN.253 metastasis		2 weeks