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

Primary Purpose

Rectum Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
preserving the left colic artery
not preserving the left colic artery
Sponsored by
Jian Suo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectum Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

preserving the left colic artery

not preserving the left colic artery

Arm Description

We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.

We preserve the high ligation of the inferior mesenteric artery during the rectal surgery.

Outcomes

Primary Outcome Measures

The Blood Pressure of the Arterial Arcade

Secondary Outcome Measures

Distal Colon Length

Full Information

First Posted
October 25, 2013
Last Updated
April 28, 2016
Sponsor
Jian Suo
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1. Study Identification

Unique Protocol Identification Number
NCT01979029
Brief Title
Study of the Preservation of the Left Colic Artery on Rectum Cancer Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jian Suo

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectum Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
preserving the left colic artery
Arm Type
Experimental
Arm Description
We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.
Arm Title
not preserving the left colic artery
Arm Type
Experimental
Arm Description
We preserve the high ligation of the inferior mesenteric artery during the rectal surgery.
Intervention Type
Procedure
Intervention Name(s)
preserving the left colic artery
Intervention Description
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 .
Intervention Type
Procedure
Intervention Name(s)
not preserving the left colic artery
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Blood Pressure of the Arterial Arcade
Time Frame
after ligating the inferior mesentric artery or superior rectal artery
Secondary Outcome Measure Information:
Title
Distal Colon Length
Time Frame
after digestive tract reconstruction
Other Pre-specified Outcome Measures:
Title
Systemic Blood Pressure
Time Frame
after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Suo, Dr.
Organizational Affiliation
Department of Gastrointestinal Surgery, First Hospital of Jilin University, Changchun, China.
Official's Role
Study Chair
Facility Information:
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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