POSSUM, P-POSSUM and Charlson's Comorbidity Index in Abdominal Surgery.

Sponsor
Ángel Becerra (Other)
Overall Status
Recruiting
CT.gov ID
NCT04774354
Collaborator
(none)
350
1
22
15.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Assessment of Surgical Risk Using the POSSUM System, P-POSSUM and Charlson's Comorbidity Index in Abdominal Surgery.
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Validate the POSSUM and P-POSSUM systems in patients undergoing gastrointestinal surgery at the Doctor Negrín University Hospital of Gran Canaria [30 days after surgery.]

      To compare the estimated morbidity and mortality with that observed.

    Secondary Outcome Measures

    1. Analyze the correlation of estimated morbidity and mortality of the POSSUM and P-POSSUM with respect to that observed in scheduled surgery vs. emergencies. [30 days after surgery.]

      To compare the estimated morbidity and mortality with that observed.

    2. Analyze the correlation of estimated morbidity and mortality of POSSUM and P-POSSUM with respect to that observed in laparoscopic surgery vs. laparotomy [30 days after surgery.]

      To compare the estimated morbidity and mortality with that observed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ángel Becerra Las Palmas De Gran Canaria Las Palmas Spain 35019

    Sponsors and Collaborators

    • Ángel Becerra

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ángel Becerra, Principal Investigator, Dr. Negrin University Hospital
    ClinicalTrials.gov Identifier:
    NCT04774354
    Other Study ID Numbers:
    • POSSUM-Negrín
    First Posted:
    Mar 1, 2021
    Last Update Posted:
    May 2, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ángel Becerra, Principal Investigator, Dr. Negrin University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 2, 2022