Factors Predicting Recurrence in Rectal Cancer After Surgery

Completed

• Conditions: Rectal Cancer; Rectal Adenocarcinoma

• Registration Number: NCT03899870
• Lead Sponsor: ammar houssem

Brief Summary

Colorectal cancer is one of the most frequently diagnosed cancers and a major cause of cancer deaths worldwide. Recurrence after curative surgery is one of the major factors affecting the long-term survival and its frequency is estimated to be 22.5% at 5 years. of which 12% have local recurrence. The overall survival in case of recurrence of 11% at 5 years.

Several patient-, tumor-related and treatment-related prognostic factors have been found to be associated with the risk of recurrence of rectal adenocarcinoma. Some of these factors such as TNM stage, lymphatic and perineural invasion and vascular emboli have been found to affect recurrence free survival in most studies. While the impact of other factors such as distal resection margin, tumor size, extra capsular spread and neoadjuvant chemoradiotherapy on recurrence remains controversial. Moreover, most of the previous studies on prognostic factors have been from American and European countries with very little data from African countries. Recognition of these factors helps in identification of high-risk patients who require close and more rigorous postoperative surveillance. Hence this study was conducted to determine the factors affecting recurrence after curative resection of rectal cancer in African population.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01-01
• Primary Completion: 2015-12-31
• Study Completion: 2019-01-15
• Status Verified: 2019-03
• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-03-30
• Last Update Submitted: 2019-03-30
• Study First Posted: 2019-04-02
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

• all the patients who underwent curative resection for rectal adenocarcinoma between January 2000 and December 2015 at the Department of Digestive and Visceral Surgery of Sahloul Hospital, Sousse, Tunisia

Exclusion Criteria

• patients who underwent palliative surgery
• patients with microscopically or macroscopically positive resection margin
• patients with tumors other than adenocarcinoma
• patients who died in the postoperative period due to complications.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence	through study completion at average of 5 years	the development of any new malignant lesion within the field of surgery (locoregional recurrence) or outside it (distant metastasis) after initial resection was judged to be curative (R0) based on the preoperative imaging and histopathological examination of the resected specimen.