Factors Predicting Recurrence in Rectal Cancer After Surgery

• Sponsor: ammar houssem (Other)
• Overall Status: Completed
• CT.gov ID: NCT03899870
• Collaborator: (none)
• Enrollment: 188
• Actual Duration (Months): 228.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer; Rectal Adenocarcinoma	Procedure: Rectal resection; Drug: Neoadjuvant therapy; Drug: Adjuvant therapy

Study Design

• Study Type: Observational
• Actual Enrollment: 188 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Factors Predicting Recurrence After Curative Resection for Rectal Cancer: a 16-year Study
• Actual Study Start Date: Jan 1, 2000
• Actual Primary Completion Date: Dec 31, 2015
• Actual Study Completion Date: Jan 15, 2019

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• ammar houssem

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ammar houssem, Surgeon, Université de Sousse
• ClinicalTrials.gov Identifier: NCT03899870
• Other Study ID Numbers: 654285
• First Posted: Apr 2, 2019
• Last Update Posted: Apr 2, 2019
• Last Verified: Mar 1, 2019

• 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 ammar houssem, Surgeon, Université de Sousse: rectal adenocarcinoma; recurrence; prognosis
• Additional relevant MeSH terms: Adenocarcinoma; Rectal Neoplasms; Recurrence

Study Results

No Results Posted as of Apr 2, 2019