Study of the Preservation of the Left Colic Artery on Rectum Cancer Surgery (POTLCAORCS)

• ClinicalTrials.gov Identifier: NCT01979029
• Recruitment Status: Completed
• First Posted: November 8, 2013
• Results First Posted: June 6, 2016
• Last Update Posted: June 6, 2016
• Sponsor: Jian Suo
• Information provided by (Responsible Party): Jian Suo, The First Hospital of Jilin University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Rectum Cancer	Procedure: preserving the left colic artery; Procedure: not preserving the left colic artery	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Study Start Date: February 2013
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: October 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: preserving the left colic artery; We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.	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 .
Experimental: not preserving the left colic artery; We preserve the high ligation of the inferior mesenteric artery during the rectal surgery.	Procedure: 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.

Outcome Measures

Primary Outcome Measures :

1. The Blood Pressure of the Arterial Arcade [ Time Frame: after ligating the inferior mesentric artery or superior rectal artery ]

Secondary Outcome Measures :

1. Distal Colon Length [ Time Frame: after digestive tract reconstruction ]

Other Outcome Measures:

1. Systemic Blood Pressure [ Time Frame: after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

China, Jilin

First Hospital of Jilin University

Changchun, Jilin, China, 130021

Sponsors and Collaborators

Jian Suo

Investigators

• Study Chair: Jian Suo, Dr.; Department of Gastrointestinal Surgery, First Hospital of Jilin University, Changchun, China.

More Information

• Responsible Party: Jian Suo, Headmaster, Dept.of General Surgery, The First Hospital of Jilin University
• ClinicalTrials.gov Identifier: NCT01979029
• Other Study ID Numbers: Left Colic Artery
• First Posted: November 8, 2013
• Results First Posted: June 6, 2016
• Last Update Posted: June 6, 2016
• Last Verified: April 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases