Postoperative ComplicationsNCT04774354
POSSUM, P-POSSUM, Clinical Frailty Scale, Clinical Frailty Scale and Charlson's Comorbidity Index in Abdominal Surgery.
An observational study of Postoperative Complications, run by Ángel Becerra-Bolaños, MD PhD at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- POSSUM
- How many people
- 350 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to 15 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- All patients undergoing scheduled or urgent intervention for gastrointestinal surgery will be included in the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Assessment of Surgical Risk Using the POSSUM, P-POSSUM, Clinical Frailty Scale 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, the Clinical Frailty Scale and the Charlson comorbidity index will be calculated.
Read the 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 Clinical Frailty Scale and Charlson Comorbidity Index with respect to morbidity and mortality at 30
- Conditions
- Postoperative Complications
- Being tested
- POSSUM
- Keywords
- postoperative complications, abdominal surgery, urgent surgery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POSSUMDiagnostic test
Also called P-POSSUM, Charlson comorbidity index, Clinical frailty scale
These scales will be calculated and compared to the outcomes obtained in our center.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: POSSUM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the POSSUM and P-POSSUM systems in patients undergoing gastrointestinal surgery
To compare the estimated morbidity and mortality with that observed.
Measured: 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.
To compare the estimated morbidity and mortality with that observed.
Measured: 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
Measured: 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Mar 2021
- Primary completion30 Mar 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ángel Becerra-Bolaños, MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ángel Becerra-Bolaños, MD PhD, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Ángel Becerra, MD PhD, Principal investigator, Hospital Universitario de Gran Canaria Doctor Negrín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774354
- Sponsor's protocol ID
- POSSUM-Negrín
- Status last verified
- Jul 2026
- First submitted
- 24 Feb 2021
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Surgical Risk Using the POSSUM, P-POSSUM, Clinical Frailty Scale and Charlson's Comorbidity Index in Abdominal Surgery.
- ClinicalTrials.gov ID
- NCT04774354
- Acronym / sponsor ID
- POSSUM-Negrín
- Conditions
- Postoperative Complications
- Keywords
- postoperative complications, abdominal surgery, urgent surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Ángel Becerra-Bolaños, MD PhDUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 Clinical Frailty Scale and Charlson Comorbidity Index with respect to morbidity and mortality at 30
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal surgery | – | Diagnostic Test: POSSUMPOSSUM, the P-POSSUM, the Clinical frailty scale, and the Charlson comorbidity index will be calculated and compared to the outcomes obtained in our center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- All patients undergoing scheduled or urgent intervention for gastrointestinal surgery will be included in the study.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POSSUMAlso: P-POSSUM, Charlson comorbidity index, Clinical frailty scaleThese scales will be calculated and compared to the outcomes obtained in our center. | Diagnostic test | Abdominal surgery |
Primary outcome
Validate the POSSUM and P-POSSUM systems in patients undergoing gastrointestinal surgery
Time frame: 30 days after surgery.
To compare the estimated morbidity and mortality with that observed.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ángel Becerra, MD PhD principal investigator
Hospital Universitario de Gran Canaria Doctor Negrín
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Ángel Becerra-Bolaños, MD PhD at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate the POSSUM and P-POSSUM systems in patients undergoing gastrointestinal surgery (time frame: 30 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.