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: Recruiting
• Conditions: Postoperative Complications
• Intervention / Treatment: Diagnostic test: POSSUM

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: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Ángel Becerra, MD; Phone Number: +34676229025; Email: angbecbol@gmail.com
• Study Contact Backup: Name: Aurelio Rodríguez Pérez, PhD; Phone Number: 928450371; Email: arodperp@gobiernodecanarias.org

Study Locations

• Spain
  • Las Palmas
    • Las Palmas De Gran Canaria, Las Palmas, Spain, 35019
      • Recruiting
      • Ángel Becerra
      • Contact: Ángel Becerra, MD; Phone Number: +34676229025
      • Contact: Email: angbecbol@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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?

Number of groups / cohorts

1

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.	Diagnostic test: POSSUM; These scales will be calculated and compared to the outcomes obtained in our center.; Other Names: P-POSSUM; Charlson comorbidity index

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	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.	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	To compare the estimated morbidity and mortality with that observed	30 days after surgery.

Collaborators and Investigators

• Sponsor: Ángel Becerra

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: postoperative complications; abdominal surgery; urgent surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: POSSUM-Negrín

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