Emergency Curative Resection of Colorectal Cancer

February 25, 2020 updated by: Mohamed El Messiry, University of Alexandria

Emergency Curative Resection of Colorectal Cancer, Do it With Caution. A Comparative Case Series

The feasibility and efficacy of emergency curative resection of complicated colorectal cancer is still controversial. This prospective study aim is to assess surgical and oncologic outcomes after emergency compared to elective curative resection of colorectal cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

60 consecutive patients presented with complicated colorectal cancer managed by emergency surgery were included and compared to another 155 consecutive patients admitted during the same period with uncomplicated colorectal cancer managed by elective surgery. Both groups were compared regarding curative resection rate, early postoperative mortality and morbidity, 3-years tumor recurrence and survival rates.

Study Type

Observational

Enrollment (Actual)

215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study included 60 consecutive patients presented by complicated colorectal cancer treated by emergency surgery at Alexandria University hospital between January 2015 and January 2017 (Group I). Another 155 patients with uncomplicated colorectal cancer treated by elective surgery during the same period were included (Group II).

Description

Inclusion Criteria:

  • All patients presented with Potentially operable colorectal cancer
  • No clinical or radiological evidence of metastatic disease

Exclusion Criteria:

  • Patients received preoperative chemoradiation
  • Patients with clinical or radiological evidence of metastatic disease
  • Patients with intraoperative evidence of metastatic disease
  • Patients with intraoperative evidence of irresectable disease
  • Patients with incomplete follow up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Emergency group
Patients presented to emergency by complicated colorectal cancer ( Obstruction, bleeding or perforation)
Procedure: Curative resection of colorectal cancer
Elective group
Patients presented with uncomplicated colorectal cancer for resection treatment
Procedure: Curative resection of colorectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequate oncologic resection
Time Frame: histopathological assessment of surgical specimens within 2 weeks postoperative
Negative resection margins + adequate lymphadenectomy ( Lymph Nodes retrieved > 12)
histopathological assessment of surgical specimens within 2 weeks postoperative
early postoperative mortality after curative resection of colorectal cancer
Time Frame: within 90 days after surgery
early death due to cause related to surgery
within 90 days after surgery
early postoperative morbidity after curative resection of colorectal cancer
Time Frame: within 90 days after surgery
surgery-related complications
within 90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor recurrence
Time Frame: By the end of the 3 years follow up period
either local or distant
By the end of the 3 years follow up period
Disease free survival
Time Frame: By the end of the 3 years follow up period
% of patients survived without recurrence
By the end of the 3 years follow up period
Overall survival
Time Frame: By the end of the 3 years follow up period
% of all patients survived either with or without recurrence
By the end of the 3 years follow up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alexandria

Investigators

  • Principal Investigator: Mohamed Elmessiry, MD, PhD, Ass. Professor of Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

February 1, 2020

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (ACTUAL)

February 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0302761

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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