NCT01979029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

June 6, 2016

Completed
Last Updated

June 6, 2016

Status Verified

April 1, 2016

Enrollment Period

1.6 years

First QC Date

October 25, 2013

Results QC Date

March 2, 2016

Last Update Submit

April 28, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Blood Pressure of the Arterial Arcade

    after ligating the inferior mesentric artery or superior rectal artery

Secondary Outcomes (1)

  • Distal Colon Length

    after digestive tract reconstruction

Other Outcomes (1)

  • Systemic Blood Pressure

    after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon

Study Arms (2)

preserving the left colic artery

EXPERIMENTAL

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

Procedure: preserving the left colic artery

not preserving the left colic artery

EXPERIMENTAL

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

Procedure: not preserving the left colic artery

Interventions

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 .

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.

not preserving the left colic artery

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Results Point of Contact

Title
Jian Suo
Organization
First Hospital of Jilin University

Study Officials

  • Jian Suo, Dr.

    Department of Gastrointestinal Surgery, First Hospital of Jilin University, Changchun, China.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Headmaster, Dept.of General Surgery

Study Record Dates

First Submitted

October 25, 2013

First Posted

November 8, 2013

Study Start

February 1, 2013

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

June 6, 2016

Results First Posted

June 6, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations