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Completed

NCT Number: NCT04293653

Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy

In the ProPEL study the effect of a protocol designed for elderly patients about to undergo emergency abdominal surgery will be investigated. The protocol addresses issues of both frailty and ceiling-of -care decisions.

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Key information

Conditions

Frailty Digestive System Diseases Frail Elderly Syndrome Gastro-Intestinal Disorder Outcome, Fatal Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Op Complication Postoperative Complications Surgery--Complications

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

About this study

In the "ProPEL" study, investigators will test the effect of a care bundle designed for patients aged ≥75 years undergoing emergency laparotomy/laparoscopy. An interdisciplinary team of anesthetists, intensivists, surgeons, and geriatricians developed the care bundle, and the essential elements are frailty scoring, surveillance and optimization of patients, surgical treatment within predefined criteria, and postoperative delirium monitoring.

Preoperatively, patients with abdominal pathology requiring emergency surgery will be evaluated for frailty by the surgical team, using standardized frailty scores. Palliative care could be an alternative to surgery in very frail patients. The decision to not perform surgery is a clinical decision made with the patient and/or relatives in a shared decision-making process. Frailty scoring can assist in this procedure.

The effect of the care-bundle will be compared to a historical cohort, using 30-day mortality as the primary outcome.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients above 75 years with clinical suspicion of abdominal condition requiring surgery

Exclusion criteria

  • Former inclusion in "ProPEL"
  • Surgery for incarcerated hernia without laparotomy
  • Appendectomy without laparotomy
  • Palliative surgery for already known inoperable gastrointestinal tumor
  • Palliation without surgical treatment
  • Vascular surgery

Treatment and study plan

Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy

Other

See above section

Primary outcomes

  1. Composite score of 30-day mortality and postoperative complications

    Time frame: Up to 30 days after the performance of emergency abdominal surgery

    Composite score will be calculated using the Comprehensive Complication Index ranging from 0 points (uneventful postoperative recovery) to 100 points (postoperative death). One investigator will review the patient's medical record postoperatively to investigate if any medical complication has occurred. Complications are defined according to the EPCO definitions and graded according to the Clavien-Dindo classification system.

Secondary outcomes

  1. Postoperative complications

    Time frame: up to 90 days after date of emergency surgery

    Number of patients having a postoperative complication as defined by the European Perioperative Clinical Outcome Definitions (EPCO) will be reported. The EPCO definitions state universal description of various common postoperative complications, like f.ex pulmonary complications, major adverse cardiac events, urinary tract infections and so on. Thus, postoperative complications are reported in a uniform way.

    We will grade complications according to the Clavien-Dindo classification. According to this classification postoperative complications are graded from 1 to 5, where 1 indicates least severity of complication and 5 indicating worst severity. We will report number of patients having complications from grade 2 to grade 5.

  2. Frequency of post-operative delirium

    Time frame: up to 30 days after emergency surgery

    Number of patients having postoperative delirium as defined by the screening tool 4 AT. On this 4-item screening tool for delirium patients are scored from 0 (minimum) up to 12 points (maximum). Screening for delirium is positive if score is 4 or above.

  3. Length of stay in hospital after EAS

    Time frame: up to 90 days after emergency surgery

    Number of days spent in hospital after EAS

  4. Patients' Level of independency as measured by the Barthel Activity of Daily Living Index before surgery and one year after surgery

    Time frame: Patients will be assessed with the BArthel ADL-index when admitted to hospital and again one year after emergency abdominal surgery.

    Activity of Daily Living (ADL) is measured using the Barthel ADL-index (Norwegian Version), a validated 10-item questionnaire. In this scale the patients level of functioning is described and assigned from 0 to 20 points. Zero points indicate total dependency and 20 points indicate Complete independency in Activities of Daily Living.

  5. Level of care at discharge from hospital and one year after EAS

    Time frame: 1 year after EAS.

    Number of patients discharged to own home after EAS. Number of patients discharged to nursing home after EAS. Number of patients living in own home or in nursing home one year after EAS.

  6. 1-year mortality

    Time frame: From time of EAS performed and up to 1 year

    Number of deaths within 1 year after emergency abdominal surgery (EAS)

  7. Days at home in first postoperative year

    Time frame: From date of discharge from hospital after EAS and up to one year postoperatively

    Number of days living in own home first year after EAS

  8. Readmissions after EAS

    Time frame: From 8 hours after primary discharge from hospital after EAS until 30 days after primary discharge.

    Number of patients readmitted to hospital after first being discharged from hospital after EAS

  9. Patient Reported Outcome Measures (PROM)one year after EAS

    Time frame: One year after procedure performed (EAS).

    Patients report on own Health performance as measured by the 36-Item Short Form Survey. In this survey patients subjective health status is described using 36 standardized questions. Patients will also be asked about their willingness to undergo same procedure again, if indicated.

  10. 5-year survival

    Time frame: From inclusion in study and up to five years after EAS.

    Number of Deaths occurring within 5 years after EAS

  11. 30-day mortality in all patients with indication to undergo surgery

    Time frame: Time (days) up to 30 days after treatment decision (palliation or surgery) is made

    30-day mortality rate in palliative and operated patients

Other outcomes

  1. 3-year survival

    Time frame: Time (days) from end of index surgery and up to 3 years after EAS.

    Number of deaths occuring within 3 years after EAS

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Acronym: (ProPEL)

Important dates

Study start
2020
Primary completion
2021
Study completion
2024
First posted
Mar 3, 2020
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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