NCT04288284

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

4.9 years

First QC Date

February 25, 2020

Last Update Submit

February 25, 2020

Conditions

Colorectal CancerOncologic Complications and Emergencies

Keywords

Complicated colorectal cancerCurative resectionSurgical and oncologic outcomes

Outcome Measures

Primary Outcomes (3)

  • Adequate oncologic resection

    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

    early death due to cause related to surgery

    within 90 days after surgery

  • early postoperative morbidity after curative resection of colorectal cancer

    surgery-related complications

    within 90 days after surgery

Secondary Outcomes (3)

  • Tumor recurrence

    By the end of the 3 years follow up period

  • Disease free survival

    By the end of the 3 years follow up period

  • Overall survival

    By the end of the 3 years follow up period

Study Arms (2)

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

Interventions

Curative resection of colorectal cancerPROCEDURE
Elective groupEmergency group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Ghazi S, Berg E, Lindblom A, Lindforss U; Low-Risk Colorectal Cancer Study Group. Clinicopathological analysis of colorectal cancer: a comparison between emergency and elective surgical cases. World J Surg Oncol. 2013 Jun 11;11:133. doi: 10.1186/1477-7819-11-133.

    PMID: 23758762BACKGROUND

  • Biondo S, Marti-Rague J, Kreisler E, Pares D, Martin A, Navarro M, Pareja L, Jaurrieta E. A prospective study of outcomes of emergency and elective surgeries for complicated colonic cancer. Am J Surg. 2005 Apr;189(4):377-83. doi: 10.1016/j.amjsurg.2005.01.009.

    PMID: 15820446BACKGROUND

  • Kim J, Mittal R, Konyalian V, King J, Stamos MJ, Kumar RR. Outcome analysis of patients undergoing colorectal resection for emergent and elective indications. Am Surg. 2007 Oct;73(10):991-3.

    PMID: 17983065BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Surgical specimens after curative resection of colorectal cancer

MeSH Terms

Conditions

Colorectal NeoplasmsEmergencies

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed Elmessiry, MD, PhD

    Ass. Professor of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Professor

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 28, 2020

Study Start

January 1, 2015

Primary Completion

December 1, 2019

Study Completion

February 1, 2020

Last Updated

February 28, 2020

Record last verified: 2020-02