Frailty(ProPEL)NCT04293653
Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy
A study testing Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy in people with Frailty and Surgery--Complications, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Surgery--Complications, Outcome, Fatal
- What is being tested?
- Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteNorway
- Study dates
- 21 Jan 2020to 2 Oct 2024
- Phase
- Interventional
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients above 75 years with clinical suspicion of abdominal condition requiring surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Frailty, Surgery--Complications, Outcome, Fatal, Frail Elderly Syndrome, Post-Op Complication, Gastro-Intestinal Disorder
- Being tested
- Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy
- Medical subject headings
- Frailty, Postoperative Complications, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol for patients above 75 undergoing emergency laparotomy or laparoscopyOther
See above section
| Study group | Role | What they receive |
|---|---|---|
| Care bundle | Experimental | Patients above 75 years where emergency surgery is indicated, deemed fit for surgery, will be included in a perioperative care-bundle. While waiting for surgery, patients will be monitored and optimized if their condition deteriorates. Antibiotics will be administered if indicated. Surgery will be delivered within 2h to 72h, depending on the suspected abdominal pathology and the patient's clinical condition. Receives: Other: Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite score of 30-day mortality and postoperative complications
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.
Measured: Up to 30 days after the performance of emergency abdominal surgery
Secondary outcomes (11)
Postoperative complications
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.
Measured: up to 90 days after date of emergency surgery
Frequency of post-operative delirium
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.
Measured: up to 30 days after emergency surgery
Length of stay in hospital after EAS
Number of days spent in hospital after EAS
Measured: up to 90 days after emergency surgery
Patients' Level of independency as measured by the Barthel Activity of Daily Living Index before surgery and one year after 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.
Measured: Patients will be assessed with the BArthel ADL-index when admitted to hospital and again one year after emergency abdominal surgery.
Level of care at discharge from hospital and one 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.
Measured: 1 year after EAS.
1-year mortality
Number of deaths within 1 year after emergency abdominal surgery (EAS)
Measured: From time of EAS performed and up to 1 year
Days at home in first postoperative year
Number of days living in own home first year after EAS
Measured: From date of discharge from hospital after EAS and up to one year postoperatively
Readmissions after EAS
Number of patients readmitted to hospital after first being discharged from hospital after EAS
Measured: From 8 hours after primary discharge from hospital after EAS until 30 days after primary discharge.
Patient Reported Outcome Measures (PROM)one year after 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.
Measured: One year after procedure performed (EAS).
5-year survival
Number of Deaths occurring within 5 years after EAS
Measured: From inclusion in study and up to five years after EAS.
30-day mortality in all patients with indication to undergo surgery
30-day mortality rate in palliative and operated patients
Measured: Time (days) up to 30 days after treatment decision (palliation or surgery) is made
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start21 Jan 2020
- Primary completion30 Jun 2021
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A care-bundle developed for patients above 75 years undergoing emergency abdominal surgery will be investigated, and the results will be compared to a group of historical controls operated at Haukeland University Hospital in 2016-2017, using 30-day mortality as the primary outcome.
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ib Jammer, MD, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293653
- Sponsor's protocol ID
- REK7110
- Acronym
- (ProPEL)
- Status last verified
- Aug 2023
- First submitted
- 2 Jan 2020
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy
- ClinicalTrials.gov ID
- NCT04293653
- Acronym / sponsor ID
- (ProPEL) / REK7110
- Conditions
- Frailty, Surgery--Complications, Outcome, Fatal, Frail Elderly Syndrome, Post-Op Complication, Gastro-Intestinal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 3 Mar 2020 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A care-bundle developed for patients above 75 years undergoing emergency abdominal surgery will be investigated, and the results will be compared to a group of historical controls operated at Haukeland University Hospital in 2016-2017, using 30-day mortality as the primary outcome.
| Arm | Type | Receives |
|---|---|---|
| Care bundle | Experimental | Other: Protocol for patients above 75 undergoing emergency laparotomy or laparoscopyPatients above 75 years where emergency surgery is indicated, deemed fit for surgery, will be included in a perioperative care-bundle. While waiting for surgery, patients will be monitored and optimized if their condition deteriorates. Antibiotics will be administered if indicated. Surgery will be delivered within 2h to 72h, depending on the suspected abdominal pathology and the patient's clinical condition. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients above 75 years with clinical suspicion of abdominal condition requiring surgery
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Protocol for patients above 75 undergoing emergency laparotomy or laparoscopySee above section | Other | Care bundle |
Primary outcome
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.
11 secondary outcomes
Postoperative complications
Time frame: up to 90 days after date of emergency surgery
Frequency of post-operative delirium
Time frame: up to 30 days after emergency surgery
Length of stay in hospital after EAS
Time frame: up to 90 days after emergency surgery
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.
Level of care at discharge from hospital and one year after EAS
Time frame: 1 year after EAS.
1-year mortality
Time frame: From time of EAS performed and up to 1 year
Days at home in first postoperative year
Time frame: From date of discharge from hospital after EAS and up to one year postoperatively
Readmissions after EAS
Time frame: From 8 hours after primary discharge from hospital after EAS until 30 days after primary discharge.
Patient Reported Outcome Measures (PROM)one year after EAS
Time frame: One year after procedure performed (EAS).
5-year survival
Time frame: From inclusion in study and up to five years after EAS.
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
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 4 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Frailty
Not yet recruiting
PROfiles of FGF-19 Post-prandial Secretion in Older Adults With Frailty and Without Frailty
Frailty, Sarcopenia
Recruiting
The VICTORY Trial: Virtual, Innovative, Postsurgical Care To Optimize Return Home for Older People With frailtY
Surgery, Frailty
Recruiting
Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Recruiting
Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
Frailty/Sarcopenia, Frailty in Older Adults
Recruiting
Frailty Training for Emergency Nurses: A Cluster RCT in Morocco
Frail Elderly, Frailty
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.
Ib Jammer, MD, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy in people with Frailty and Surgery--Complications, run by Haukeland University Hospital at 1 site in Norway.
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 6 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 4 Oct 2024. 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 Norway. 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?
Composite score of 30-day mortality and postoperative complications (time frame: Up to 30 days after the performance of emergency abdominal 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 4 Oct 2024.