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P-POSSUM for Outcomes After Abdominal Surgery (PPOSSUM-ABD)

21. Juni 2026 aktualisiert von: Nguyen Toan Thang, Bach Mai Hospital

Postoperative complications after abdominal surgery can lead to prolonged recovery, intensive care admission, and death. The P-POSSUM score is a commonly used surgical risk prediction tool, but its performance may vary between hospitals and patient populations. Frailty, especially in older patients, may also affect postoperative outcomes and may improve risk prediction when added to existing scoring systems.

This ambispective observational cohort study evaluates the prognostic value of the P-POSSUM score, with additional assessment of frailty and routine perioperative clinical data, for predicting postoperative complications and treatment outcomes in adult patients undergoing abdominal surgery at Bach Mai Hospital. The study includes retrospective data from January 2025 and prospective data collection through May 2026. No intervention is assigned by the investigators. All patients receive routine perioperative care according to clinical practice.

The study will assess the predictive performance of P-POSSUM for postoperative complications and mortality, and will explore whether adding frailty-related variables improves risk prediction.

Studienübersicht

Detaillierte Beschreibung

Postoperative complications remain an important cause of morbidity, prolonged hospital stay, intensive care use, and mortality after abdominal surgery. Risk prediction before and after surgery may help clinicians identify high-risk patients, guide perioperative planning, and improve postoperative monitoring. The Portsmouth Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity, known as P-POSSUM, combines physiological and operative variables to estimate the risk of postoperative morbidity and mortality. However, the performance of P-POSSUM may differ across populations, surgical settings, and healthcare systems.

Frailty is increasingly recognized as an important predictor of adverse postoperative outcomes, particularly in older surgical patients. Frailty reflects reduced physiological reserve and increased vulnerability to acute stressors such as emergency surgery, infection, bleeding, and postoperative critical illness. In this study, frailty will be assessed using routinely available clinical information. For retrospective data, frailty-related status will be evaluated using available medical records and a modified frailty index when sufficient data are available. For prospectively enrolled patients, frailty will be assessed based on baseline functional status before the acute surgical illness, using a standardized clinical frailty assessment when feasible.

This study is designed as an ambispective observational cohort study conducted at the Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital, Vietnam. The study includes retrospective data from patients undergoing abdominal surgery from January 2025 and prospective data collection through May 2026. Eligible adult patients undergoing abdominal surgery will be included according to predefined selection criteria. The investigators will not assign any intervention or modify treatment decisions. Perioperative management, surgical care, anesthesia, postoperative monitoring, and intensive care treatment will be provided according to routine clinical practice.

For each eligible patient, demographic characteristics, comorbidities, physiological variables, operative severity variables, frailty-related variables, perioperative laboratory results, anesthesia and surgical information, postoperative complications, and treatment outcomes will be collected. The P-POSSUM score will be calculated using the predefined physiological and operative scoring components. Study outcomes will be obtained from hospital medical records, anesthesia records, surgical records, intensive care charts, laboratory data, and discharge documentation.

The primary objective is to evaluate the prognostic performance of P-POSSUM for postoperative complications after abdominal surgery. Secondary objectives include evaluating the performance of P-POSSUM for postoperative mortality and other treatment outcomes, assessing calibration and discrimination of the score, and exploring whether the addition of frailty-related variables and routinely available perioperative data improves risk prediction compared with P-POSSUM alone.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

3000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Hanoi
      • Hanoi, Hanoi, Vietnam, 00000
        • Bach Mai Hospital, Hanoi, Viet Nam.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Older adult patients aged 60 years or older undergoing abdominal surgery at Bach Mai Hospital. The study population includes patients identified from retrospective hospital records from January 2025 and prospectively collected data through May 2026. P-POSSUM variables, frailty-related variables, routine perioperative clinical data, postoperative complications, and treatment outcomes will be collected for prognostic evaluation.

Beschreibung

Inclusion Criteria:

Patients aged 60 years or older. Patients undergoing abdominal surgery at Bach Mai Hospital. Patients managed perioperatively or postoperatively by the Center for Anesthesia and Surgical Intensive Care.

Patients with available perioperative clinical data required to calculate the P-POSSUM score.

Patients with available baseline clinical, comorbidity, or functional status information for frailty assessment.

Patients with available postoperative outcome data for assessment of complications, mortality, or treatment outcomes.

Exclusion Criteria:

Patients younger than 60 years. Patients not undergoing abdominal surgery. Patients undergoing minor procedures without operative severity data required for P-POSSUM calculation.

Patients with missing key physiological or operative variables required to calculate the P-POSSUM score.

Patients with insufficient baseline information for frailty assessment. Patients with insufficient postoperative follow-up data for outcome assessment.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Abdominal Surgery Cohort
Adult patients undergoing abdominal surgery at Bach Mai Hospital who meet the study eligibility criteria. Participants will be identified from retrospective records from January 2025 and prospectively collected data through May 2026. No intervention will be assigned by the investigators. P-POSSUM physiological and operative variables, frailty-related variables, routine perioperative clinical data, postoperative complications, and treatment outcomes will be collected to evaluate prognostic performance and risk prediction.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of patients with postoperative complications within 30 days after abdominal surgery
Zeitfenster: Within 30 days after surgery or until hospital discharge, whichever occurs first
The proportion of patients who develop one or more postoperative complications after abdominal surgery. Postoperative complications include surgical, infectious, respiratory, cardiovascular, renal, neurological, bleeding-related, or other clinically documented complications requiring treatment, monitoring, ICU care, reoperation, or other medical intervention. Complications will be identified from anesthesia records, surgical records, ICU charts, laboratory and imaging results, discharge summaries, and hospital medical records. This outcome will be used to evaluate the prognostic performance of P-POSSUM and frailty-enhanced risk prediction.
Within 30 days after surgery or until hospital discharge, whichever occurs first

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
All-cause mortality within 30 days after abdominal surgery
Zeitfenster: Within 30 days after surgery or until hospital discharge, whichever occurs first
All-cause mortality after abdominal surgery will be recorded from hospital medical records, ICU records, discharge documentation, and follow-up information when available. This outcome will be used to assess the prognostic performance of P-POSSUM and frailty-related variables for postoperative mortality.
Within 30 days after surgery or until hospital discharge, whichever occurs first
Discrimination of P-POSSUM for postoperative complications
Zeitfenster: Postoperative complications occurring from the end of surgery through 30 days after surgery or hospital discharge, whichever occurs first.
The discrimination of the P-POSSUM score for postoperative complications will be assessed using the area under the receiver operating characteristic curve. The area under the receiver operating characteristic curve will be reported as a single unitless measure, calculated for postoperative complications occurring within 30 days after surgery or before hospital discharge, whichever occurs first.
Postoperative complications occurring from the end of surgery through 30 days after surgery or hospital discharge, whichever occurs first.
Incremental discrimination of frailty-related variables added to P-POSSUM
Zeitfenster: Postoperative complications occurring from the end of surgery through 30 days after surgery or hospital discharge, whichever occurs first.
The incremental predictive value of frailty-related variables added to the P-POSSUM score will be assessed by the change in area under the receiver operating characteristic curve between the model including P-POSSUM alone and the model including P-POSSUM plus frailty-related variables. The change in area under the receiver operating characteristic curve will be reported as a single unitless measure.
Postoperative complications occurring from the end of surgery through 30 days after surgery or hospital discharge, whichever occurs first.
Intensive care unit length of stay
Zeitfenster: From ICU admission until ICU discharge or death, assessed up to 30 days after ICU admission.
Intensive care unit length of stay will be reported as a single continuous measure in days. It will be calculated from the recorded date and time of ICU admission to the recorded date and time of ICU discharge or death, whichever occurs first, using ICU charts and hospital medical records.
From ICU admission until ICU discharge or death, assessed up to 30 days after ICU admission.
Hospital length of stay
Zeitfenster: From hospital admission until hospital discharge or in-hospital death, assessed up to 90 days after hospital admission.
Hospital length of stay will be reported as a single continuous measure in days. It will be calculated from the date of hospital admission to the date of hospital discharge or in-hospital death, whichever occurs first, using hospital administrative records and discharge documentation.
From hospital admission until hospital discharge or in-hospital death, assessed up to 90 days after hospital admission.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Januar 2026

Primärer Abschluss (Geschätzt)

30. Juni 2026

Studienabschluss (Geschätzt)

30. Juni 2026

Studienanmeldedaten

Zuerst eingereicht

16. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Juni 2026

Zuerst gepostet (Tatsächlich)

25. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data underlying the main published results may be shared upon reasonable request. Shared data may include baseline demographic and clinical characteristics, P-POSSUM physiological and operative variables, frailty-related variables, routine perioperative data, postoperative complications, mortality, length of stay, and other treatment outcomes used in the final analysis. No directly identifiable participant information will be shared.

IPD-Sharing-Zeitrahmen

De-identified individual participant data and supporting documents will be available after publication of the main study results. There is no predetermined end date for data availability; requests will be considered according to institutional policies, ethics requirements, and data sharing agreements.

IPD-Sharing-Zugriffskriterien

Data may be shared with qualified researchers for systematic reviews, meta-analyses, external validation, or scientifically valid secondary analyses. Access will require submission of a research proposal, approval by an ethics committee when applicable, and a signed data sharing agreement with the study custodian or sponsor. Requests should be sent to the study contact. Shared data will be de-identified and limited to variables necessary for the approved analysis.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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