- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04774354
POSSUM, P-POSSUM and Charlson's Comorbidity Index in Abdominal Surgery.
Prospective Assessment of Surgical Risk Using the POSSUM System, P-POSSUM and Charlson's Comorbidity Index in Abdominal Surgery.
Abdominal surgery represents the most frequent activity in the surgical block. Advances in surgical techniques and improvements in postoperative care imply the need for greater control of the surgical outcomes obtained and the comparison of results between services with the same characteristics with the help of assessment scales.
A prospective observational study will be carried out during 2021. All patients undergoing abdominal surgery will be included. Demographic variables, personal and surgical history, preoperative and intraoperative data, and variables related to surgery will be collected. At 30 days postoperatively, the clinical history of the patients will be reviewed and postoperative complications will be collected as well as the mortality that occurred. With these data, the POSSUM, the P-POSSUM and the Charlson comorbidity index will be calculated.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Abdominal surgery represents the most frequent activity in the surgical block. Advances in surgical techniques and improvements in postoperative care imply the need for greater control of the surgical outcomes obtained and the comparison of results between services with the same characteristics with the help of assessment scales.
A prospective observational study will be carried out during 2021. All patients undergoing abdominal surgery will be included. Demographic variables, personal and surgical history, preoperative and intraoperative data, and variables related to surgery will be collected. At 30 days postoperatively, the clinical history of the patients will be reviewed and postoperative complications will be collected as well as the mortality that occurred. With these data, the POSSUM, the P-POSSUM and the Charlson comorbidity index will be calculated.
Once this data are collected, the following objectives will be met:
- Validate the POSSUM and P-POSSUM systems in patients undergoing gastrointestinal surgery in our hospital, comparing the estimated morbidity and mortality with that observed 30 days after surgery.
- Analyze the correlation of estimated morbidity and mortality of the POSSUM and P-POSSUM with respect to that observed in scheduled surgery vs. emergencies.
- Analyze the correlation of estimated morbidity and mortality of POSSUM and P-POSSUM with respect to that observed in laparoscopic surgery vs. laparotomy
- Establish the relationship and predictive ability of CHF with respect to morbidity and mortality at 30
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Las Palmas
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Las Palmas De Gran Canaria, Las Palmas, Spain, 35019
- Ángel Becerra
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
A prospective observational study will be carried out in which all patients undergoing gastrointestinal surgery will be included, both scheduled and urgently.
At 30 days postoperatively, the clinical records of the patients will be reviewed in order to establish the incidence of morbidity and mortality.
Description
Inclusion Criteria:
- All patients undergoing scheduled or urgent intervention for gastrointestinal surgery will be included in the study.
Exclusion Criteria:
- Patients operated under locoregional anesthesia.
- Patients undergoing Major Ambulatory Surgery (CMA) regardless of postoperative destination (home or hospitalization floor).
- Patients intervened on a scheduled basis in the afternoon shift
- Patients who require surgery after the first 24 hours of hospital admission
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Abdominal surgery
POSSUM, the P-POSSUM and the Charlson comorbidity index will be calculated and compared to the outcomes obtained in our center.
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These scales will be calculated and compared to the outcomes obtained in our center.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Validate the POSSUM and P-POSSUM systems in patients undergoing gastrointestinal surgery at the Doctor Negrín University Hospital of Gran Canaria
Time Frame: 30 days after surgery.
|
To compare the estimated morbidity and mortality with that observed.
|
30 days after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analyze the correlation of estimated morbidity and mortality of the POSSUM and P-POSSUM with respect to that observed in scheduled surgery vs. emergencies.
Time Frame: 30 days after surgery.
|
To compare the estimated morbidity and mortality with that observed.
|
30 days after surgery.
|
|
Analyze the correlation of estimated morbidity and mortality of POSSUM and P-POSSUM with respect to that observed in laparoscopic surgery vs. laparotomy
Time Frame: 30 days after surgery.
|
To compare the estimated morbidity and mortality with that observed
|
30 days after surgery.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POSSUM-Negrín
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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