POSSUM, P-POSSUM, Clinical Frailty Scale, Clinical Frailt... | NCT04774354

Studies
POSSUM, P-POSSUM, Clinical Frailty Scale, Clinical Frailty Scale and Charlson's Comorbidity Index in Abdominal Surgery.

NCT04774354

Sponsor

Ángel Becerra-Bolaños, MD PhD

Status

Completed

Last Update Posted

Jul 7, 2026Actual

Enrollment

350Actual

Phase

Not provided

Conditions

Postoperative Complications

Interventions

POSSUM

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Mar 30, 2025Actual

Completion Date

Apr 15, 2025Actual

First Submitted Date

Feb 24, 2021

First Submission Date that Met QC Criteria

Feb 24, 2021

First Posted Date

Mar 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2026

Last Update Posted Date

Jul 7, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ángel Becerra-Bolaños, MD PhD, Principal Investigator, Hospital Universitario de Gran Canaria Doctor NegrínSponsor-Investigator

Lead Sponsor

Ángel Becerra-Bolaños, MD PhDOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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, the Clinical Frailty Scale and the Charlson comorbidity index will be calculated.

Detailed Description

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 Clinical Frailty Scale and Charlson Comorbidity Index with respect to morbidity and mortality at 30

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

350Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Abdominal surgery		POSSUM, the P-POSSUM, the Clinical frailty scale, and the Charlson comorbidity index will be calculated and compared to the outcomes obtained in our center.	Diagnostic Test: POSSUM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
POSSUM	Diagnostic Test	These scales will be calculated and compared to the outcomes obtained in our center.	Abdominal surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Validate the POSSUM and P-POSSUM systems in patients undergoing gastrointestinal surgery	To compare the estimated morbidity and mortality with that observed.	30 days after surgery.

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ángel Becerra, MD PhD	Hospital Universitario de Gran Canaria Doctor Negrín	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ángel Becerra		Las Palmas de Gran Canaria	Las Palmas	35019	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 1, 2021	Oct 27, 2025	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided