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Completed

NCT Number: NCT04260139

Lymph Node Yield in Colon Cancer Resection Specimens

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lymph Node Metastases Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bagcılar Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calculation of metric variables on the colectomy specimens.

Procedure

Calculation of metric variables on the colectomy specimens including Lengths as mm

  • Proximal colon,
  • Ileum in cases with right hemicolectomy only,
  • Proximal border,
  • Tumor,
  • Distal border,
  • Total specimen,
  • Vascular pedicle, the longitudinal distance between the nearest bowel wall and the end of ligated major vascular pedicle depending on the tumor's localization, 2. Colonic mesenteric area as mm2.

Primary outcomes

  1. Lymph Node Yield in Colon Cancer Resection Specimens

    Time frame: September 2019- November 2020

    Count of lymph node

  2. Lymph Node Yield in Colon Cancer Resection Specimens

    Time frame: September 2019-November 2020

    Involvement of lymph node

Sponsors and collaborators

Lead sponsor

Bagcilar Training and Research Hospital

Other Gov

Registry information

Official study title

Macroscopic Evaluation of Colon Cancer Resection Specimens to Predict Metastatic Lymph Node Yield

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 7, 2020
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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