Lymph Node Yield in Colon Cancer Resection Specimens

Sponsor
Bagcilar Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04260139
Collaborator
(none)
50
1
13
3.8

Study Details

Study Description

Brief Summary

In this study, we aimed to develop a predictive model of lymph node yield in a series of colon cancer resection specimens with detailed anatomic and surgical technique data.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Calculation of metric variables on the colectomy specimens.

Detailed Description

Lymph node yield in colon resection specimens has been associated with the accuracy of staging and cancer outcomes. It has been proposed that the more central the mesenteric vascular ligation, the greater the nodal yield. However, the optimal number of harvested nodes is still a matter of debate. We prospectively evaluated the relation between specimen properties such as lenght, area, tumor location and pedicle length to the number of harvested nodes and rate of node positivity.

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Macroscopic Evaluation of Colon Cancer Resection Specimens to Predict Metastatic Lymph Node Yield
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Jul 1, 2020
Actual Study Completion Date :
Oct 1, 2020

Outcome Measures

Primary Outcome Measures

  1. Lymph Node Yield in Colon Cancer Resection Specimens [September 2019- November 2020]

    Count of lymph node

  2. Lymph Node Yield in Colon Cancer Resection Specimens [September 2019-November 2020]

    Involvement of lymph node

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

The surgical patients with a histologic diagnosis of colonic neoplasm, Colectomy of any type, including the right hemicolectomy, the left hemicolectomy, the sigmoid resection, segmental colon resection

Exclusion Criteria:
  • rectal or rectosigmoid cancer colectomy beyond the inclusion criteria for colectomies patients younger than 18 previous colon resection emergency colon resection familial adenomatous polyposis or ulcerative colitis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bagcılar Training and Research Hospital Istanbul Turkey

Sponsors and Collaborators

  • Bagcilar Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nadir Adnan Hacım, Dr., Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04260139
Other Study ID Numbers:
  • Beren Hacım
First Posted:
Feb 7, 2020
Last Update Posted:
Nov 13, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nadir Adnan Hacım, Dr., Bagcilar Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2020