MortalityMECCNCT04538404
Mortality Score in Elderly Patients With Colon Cancer
An observational study of Mortality and Surgery, run by University of Bologna at 2 sites in Italy.
Trial summary
CR-POSSUM is one of the most used surgical scores to predict mortality after colorectal surgery. Its main drawback is the requirement of intraoperative variables, whose collection is time-consuming and prevents from obtaining a purely preoperative risk assessment. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Mortality, Surgery, Colon Cancer
- What is being tested?
- Colon Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 385 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2011to 31 Jan 2019
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Men and women patients aged 80 and above having elective and emergency colonic resection for colon cancer via open, laparoscopic and converted approaches.
Who may be able to join
- Patients aged 80 and above having elective and emergency colonic resection for colon cancer via open, laparoscopic and converted approaches
Who cannot join
- Surgical resections for rectal cancer and surgical procedures for non-neoplastic colon pathologies
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Score for the Prediction of Mortality Risk After Surgery for Colon Cancer in a Case Series of Elderly Patients
CR-POSSUM is one of the most used surgical scores to predict mortality after colorectal surgery. Its main drawback is the requirement of intraoperative variables, whose collection is time-consuming and prevents from obtaining a purely preoperative risk assessment. The primary aim of the study is to develop a new surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population. The secondary objective is to analyze its efficacy compared to CR-POSSUM.
Read the detailed description
Patients aged 80 and older undergoing surgery for colon cancer from 2011 to 2017 in an Italian hospital were retrospectively selected. MECC score [Mortality in Elderly patients with Colon Cancer] was calculated summing up the scores relating to: arterial saturation of O2, Systolic Blood Pressure, Heart Rate, WBCs, Albumin, Creatinine. Once CR-POSSUM was calculated, the two scores were compared.
- Conditions
- Mortality, Surgery, Colon Cancer
- Being tested
- Colon Surgery
- Keywords
- colon cancer, surgery, mortality, elderly, scoring system
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon SurgeryProcedure or surgery
Right, left colon surgery, transverse colon surgery, multiple colon surgery in open and minimally invasive surgert
What is being measured
The primary outcome is the main question the study is designed to answer.
New surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population
MEC Score (arterial saturation of O2, Systolic Blood Pressure, Heart Rate, WBCs, Albumin, Creatinine) for the evaluation of the risk of in-hospital mortality occurred during hospitalization up to 30 days
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Jan 2011
- Primary completion31 Aug 2017
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MortalityStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marialuisa Lugaresi, University of Bologna
- Investigators
- Bruno Nardo, MD,PhD, Study director, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538404
- Sponsor's protocol ID
- MECC Score
- Acronym
- MECC
- Status last verified
- Aug 2020
- First submitted
- 22 Aug 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Score for the Prediction of Mortality Risk After Surgery for Colon Cancer in a Case Series of Elderly Patients
- ClinicalTrials.gov ID
- NCT04538404
- Acronym / sponsor ID
- MECC / MECC Score
- Conditions
- Mortality, Surgery, Colon Cancer
- Keywords
- colon cancer, surgery, mortality, elderly, scoring system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 4 Sep 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.
CR-POSSUM is one of the most used surgical scores to predict mortality after colorectal surgery. Its main drawback is the requirement of intraoperative variables, whose collection is time-consuming and prevents from obtaining a purely preoperative risk assessment. The primary aim of the study is to develop a new surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population. The secondary objective is to analyze its efficacy compared to CR-POSSUM.
Detailed description
Patients aged 80 and older undergoing surgery for colon cancer from 2011 to 2017 in an Italian hospital were retrospectively selected. MECC score [Mortality in Elderly patients with Colon Cancer] was calculated summing up the scores relating to: arterial saturation of O2, Systolic Blood Pressure, Heart Rate, WBCs, Albumin, Creatinine. Once CR-POSSUM was calculated, the two scores were compared.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Men and women patients aged 80 and above having elective and emergency colonic resection for colon cancer via open, laparoscopic and converted approaches.
Key inclusion criteria (1 listed)
- Patients aged 80 and above having elective and emergency colonic resection for colon cancer via open, laparoscopic and converted approaches
Key exclusion criteria (1 listed)
- Surgical resections for rectal cancer and surgical procedures for non-neoplastic colon pathologies
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 |
|---|---|---|
| Colon SurgeryRight, left colon surgery, transverse colon surgery, multiple colon surgery in open and minimally invasive surgert | Procedure or surgery | – |
Primary outcome
New surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population
Time frame: Up to 30 days after surgery
MEC Score (arterial saturation of O2, Systolic Blood Pressure, Heart Rate, WBCs, Albumin, Creatinine) for the evaluation of the risk of in-hospital mortality occurred during hospitalization up to 30 days
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 4 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Bruno Nardo, MD,PhD study director
University of Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mortality and Surgery, run by University of Bologna at 2 sites in Italy.
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 1 inclusion and 1 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 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
New surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population (time frame: Up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2020.