Study of the Preservation of the Left Colic Artery on Rectum Cancer Surgery

Rectum Cancer Clinical Trial

— POTLCAORCS  

Official title:

Affection on Anastomotic Blood Flow and the Lymph Nodes Dissection Between Division at the Root of the Inferior Mesenteric Artery and Preserving the Left Colic Artery in Rectum Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01979029
• Other study ID #: Left Colic Artery
• Status: Recruiting
• Phase: N/A
• First received: October 25, 2013
• Last updated: October 12, 2014
• Start date: February 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: First Hospital of Jilin University
• Contact: Jian Suo, Dr.
• Phone: 86-0431-88782737
• Email: suojian42[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To evaluate the influence to the blood supply of the anastomosis and the harvest of the No. 253 lymph nodes in different surgical methods--- preserving the left colic artery (LCA) and resect the No. 253 lymph node specifically in the radical resection of rectal carcinoma or dividing at the root of the inferior mesenteric artery (IMA) in the radical resection of rectal carcinoma.

Description:

Methods: The patients who got rectal carcinoma are divided into two groups. Both groups will receive the radical resection of rectal carcinoma. We preserve the left colic artery and resect the No. 253 lymph node specifically in Group A and divide at the root of the inferior mesenteric artery in Group B, We insert a trocar into the arterial arcade at the proximal site of the anastomosis and measure the blood pressure of the arterial arcade in the operation, which can reflect the blood supply of the anastomosis. Besides, We will measure the length of the colon from the anastomosis to the level of the root of the IMA. Expecting Results：The blood pressure of the arterial arcade in Group A will be higher than that in Group B. And the patients in Group A will have less chance to get anastomotic fistula. Expecting Conclusions: Preserving the LCA and resecting the No. 253 lymph node specifically in the radical resection of rectal carcinoma can improve the blood supply of the anastomosis and decrease the incidence of anastomotic fistula, and won't affect the harvest of the No. 253 lymph node.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients coming to FirstJilinU diagnosed rectum cancer by endoscopy and pathology.

• The rectum cancer is the first malignant neoplasm the patient has got.

• The cancer is solitary, and is 3cm to 20cm to the anus.

• The surgical method is limited to Dixon.

Exclusion Criteria:

• Being in the acute phase of inflammation before operation and emergency surgery.

• Patients receiving steroid medication or preoperative radiotherapy?

• Discovering macrometastasis before or in the operation.

• The rectum cancer that can't be radical resected.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Neoplasms
• Rectum Cancer

Intervention

Procedure:
• preserving the left colic artery
The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA .
• not preserving the left colic artery
The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves.

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Jian Suo

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	systemic blood pressure		at the time measuring the blood pressure of the arterial arcade	No
Primary	The blood pressure of the arterial arcade		after ligating the inferior mesentric artery or superior rectal artery	No
Secondary	distal colon length		after digestive tract reconstruction	No