NCT04774354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

4.1 years

First QC Date

February 24, 2021

Last Update Submit

April 16, 2025

Conditions

Keywords

postoperative complicationsabdominal surgeryurgent surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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.

  • 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.

Study Arms (1)

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

Interventions

POSSUMDIAGNOSTIC_TEST

These scales will be calculated and compared to the outcomes obtained in our center.

Also known as: P-POSSUM, Charlson comorbidity index
Abdominal surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All patients undergoing scheduled or urgent intervention for gastrointestinal surgery will be included in the study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2021

First Posted

March 1, 2021

Study Start

March 1, 2021

Primary Completion

March 30, 2025

Study Completion

April 15, 2025

Last Updated

April 20, 2025

Record last verified: 2025-04

Locations