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

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

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.

Study Overview

• Status: Completed
• Conditions: Rectum Cancer
• Intervention / Treatment: Procedure: preserving the left colic artery; Procedure: not preserving the left colic artery

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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Blood Pressure of the Arterial Arcade	after ligating the inferior mesentric artery or superior rectal artery

Secondary Outcome Measures

Outcome Measure	Time Frame
Distal Colon Length	after digestive tract reconstruction

Other Outcome Measures

Outcome Measure	Time Frame
Systemic Blood Pressure	after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Estimate): June 6, 2016
• Last Update Submitted That Met QC Criteria: April 28, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: Left Colic Artery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO