Prognostic Factors Affecting Recurrence and Disease-Free Survival After Surgical Resection for Cancer Rectum

Recruiting

• Conditions: Rectal Cancer
• Interventions: Procedure: curative surgery for cancer rectum

• Registration Number: NCT06096493
• Lead Sponsor: South Valley University

Brief Summary

Tumor recurrence after curative surgical resection for rectal cancer is a serious complication that greatly affects the overall morbidity and the outcome. This study aims to identify the different prognostic factors affecting recurrence and disease-free survival after surgery.

Detailed Description

A retrospective analysis of patients operated for cancer rectum with curative intent from.

Exclusion criteria will include patients with familial adenomatous polyposis, multiple synchronous or metachronous rectal cancers, and death within 3 months. Incomplete patients' files and patients that lost follow-up will be excluded.

Demographic, histopathological, follow up and outcome data will be collected from completed patients' files. Demographics include age, gender, family history, and chief complaint at the presentation. Histopathological data include tumor grade, vascular-perineural invasion, the total number of lymph nodes removed, and positive lymph nodes.

Lymph node ratio will be defined as the ratio of positive lymph nodes to the total number of retrieved lymph nodes in a histopathology specimen. Disease-free survival will be calculated for each patient based on the time of surgery to the time of recurrence detection.

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-21
• Last Update Submitted: 2023-10-21
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients who had curative surgery for cancer rectum.

Exclusion Criteria

• Patients with familial adenomatous polyposis (FAP), multiple synchronous or metachronous rectal cancers, and death within 3 months
• Patients that lost follow-up will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with cancer rectum underwent curative surgery	curative surgery for cancer rectum	Patients with cancer rectum underwent curative surgery

Primary Outcome Measures

Name	Time	Method
Tumor recurrence	Through study completion, an average of 3 year	Presence of Tumor recurrence after curative surgery for cancer rectum.
Disease free survival.	up to 5 years	From date of surgery until the date of recurrence detection.

Trial Locations

Locations (1)

Qena Faculty of Medicine, South Valley University Hospitals; 🇪🇬 Qinā, Egypt