Colorectal CancerNCT04288284
Emergency Curative Resection of Colorectal Cancer
An observational study of Colorectal Cancer and Oncologic Complications and Emergencies, run by University of Alexandria.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer, Oncologic Complications and Emergencies
- What is being tested?
- Curative resection of colorectal cancer
- Type of treatment
- Surgery or procedure
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- All patients presented with Potentially operable colorectal cancer
- No clinical or radiological evidence of metastatic disease
Who cannot join
- 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
About this study
Official title: 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
Read the 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.
- Being tested
- Curative resection of colorectal cancer
- Keywords
- Complicated colorectal cancer, Curative resection, Surgical and oncologic outcomes
- Medical subject headings
- Colorectal Neoplasms, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curative resection of colorectal cancerProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Emergency group | Patients presented to emergency by complicated colorectal cancer ( Obstruction, bleeding or perforation) Receives: Procedure: Curative resection of colorectal cancer | |
| Elective group | Patients presented with uncomplicated colorectal cancer for resection treatment Receives: Procedure: Curative resection of colorectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate oncologic resection
Negative resection margins + adequate lymphadenectomy ( Lymph Nodes retrieved > 12)
Measured: 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
Measured: within 90 days after surgery
early postoperative morbidity after curative resection of colorectal cancer
surgery-related complications
Measured: within 90 days after surgery
Secondary outcomes (3)
Tumor recurrence
either local or distant
Measured: By the end of the 3 years follow up period
Disease free survival
% of patients survived without recurrence
Measured: By the end of the 3 years follow up period
Overall survival
% of all patients survived either with or without recurrence
Measured: By the end of the 3 years follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study startJan 2015
- Primary completionDec 2019
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed El Messiry, University of Alexandria
- Investigators
- Mohamed Elmessiry, MD, PhD, Principal investigator, Ass. Professor of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288284
- Sponsor's protocol ID
- 0302761
- Status last verified
- Feb 2020
- First submitted
- 25 Feb 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23758762Biondo 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.
PubMed 15820446Kim 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.
PubMed 17983065
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Curative Resection of Colorectal Cancer, Do it With Caution. A Comparative Case Series
- ClinicalTrials.gov ID
- NCT04288284
- Acronym / sponsor ID
- 0302761
- Keywords
- Complicated colorectal cancer, Curative resection, Surgical and oncologic outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency group | – | Procedure: Curative resection of colorectal cancerPatients presented to emergency by complicated colorectal cancer ( Obstruction, bleeding or perforation) |
| Elective group | – | Procedure: Curative resection of colorectal cancerPatients presented with uncomplicated colorectal cancer for resection treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- All patients presented with Potentially operable colorectal cancer
- No clinical or radiological evidence of metastatic disease
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curative resection of colorectal cancer | Procedure or surgery | Elective group, Emergency group |
Primary outcome
Adequate oncologic resection
Time frame: histopathological assessment of surgical specimens within 2 weeks postoperative
Negative resection margins + adequate lymphadenectomy ( Lymph Nodes retrieved > 12)
early postoperative mortality after curative resection of colorectal cancer
Time frame: within 90 days after surgery
early death due to cause related to surgery
early postoperative morbidity after curative resection of colorectal cancer
Time frame: within 90 days after surgery
surgery-related complications
3 secondary outcomes
Tumor recurrence
Time frame: 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
Overall survival
Time frame: By the end of the 3 years follow up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Background: PubMed 23758762Ghazi 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.
- Background: PubMed 15820446Biondo 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.
- Background: PubMed 17983065Kim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Elmessiry, MD, PhD principal investigator
Ass. Professor of Surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Oncologic Complications and Emergencies, run by University of Alexandria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate oncologic resection (time frame: histopathological assessment of surgical specimens within 2 weeks postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04288284, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.