Prognostic Significance of Lymph Node Ratio in Rectal Cancer on Overall Survival

Sponsor
South Valley University (Other)
Overall Status
Completed
CT.gov ID
NCT05667259
Collaborator
(none)
229
1
131
1.7

Study Details

Study Description

Brief Summary

This study was conducted to compare the significance of lymph node ratio and absolute count of positive lymph node count on overall survival in patients with rectal cancer who underwent resection with curative intent

Condition or Disease Intervention/Treatment Phase
  • Other: Surgical resection for cancer rectum

Detailed Description

Retrospective cohort study carried on 229 patients with non-metastatic rectal cancer, admitted in tertiary hospitals along 10 years, between 2012 to 2022, and underwent radical resection surgery with curative intent.

Exclusion criteria included patients with familial adenomatous polyposis, multiple synchronous or metachronous rectal cancers, early post-operative recurrence or death within 3 months. Demographic, histopathological, follow up and outcome data were collected.

Demographics included age, gender, family history, and chief complaint at presentation. Histopathological data included tumor site, grade, vascular-perineural invasion, total number of lymph nodes removed, and positive lymph nodes.

Lymph node ratio was defined as the ratio of positive lymph nodes to the total number of retrieved lymph nodes in histopathology specimen. Survival was calculated for each patient based on time of surgery to time of death

Statistical analysis will be used to evaluate the effect of lymph node ratio on overall survival.

Study Design

Study Type:
Observational
Actual Enrollment :
229 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Prognostic Significance of Lymph Node Ratio in Rectal Cancer on Overall Survival: An Alternative Not a Substitute
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Overall Survival [up to 10 years (From date of surgery to the date date of death)]

    Survival was calculated for each patient based on time of surgery to time of death.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient with rectal cancer of stage I-III.

  • patients underwent radical resection with curative intent.

Exclusion Criteria:
  • Patients with Familial Adenomatous Polyposis, multiple synchronous or metachronous rectal cancers.

  • Early post-operative recurrence, or death within 3 months.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qena Faculty of Medicine, South Valley University Hospitals Qinā Egypt

Sponsors and Collaborators

  • South Valley University

Investigators

  • Principal Investigator: Abdallah M Taha, MD, Egypt, South Valley University, Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abdallah Mohamed Taha Aly, Associate professor of General Surgry, South Valley University
ClinicalTrials.gov Identifier:
NCT05667259
Other Study ID Numbers:
  • SVU-MED-SUR011-4-22-10-464
First Posted:
Dec 28, 2022
Last Update Posted:
Dec 28, 2022
Last Verified:
Dec 1, 2022
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 Abdallah Mohamed Taha Aly, Associate professor of General Surgry, South Valley University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 28, 2022