An Investigation of Frailty Markers and Outcomes in Patients Requiring Emergency Laparotomy

Surgery Clinical Trial

Official title: An Investigation of Frailty Markers and Outcomes in Patients Requiring Emergency Laparotomy

Status Recruiting

Clinical Trial Summary

Over 30,000 emergency abdominal operations (laparotomy, EmLAP) are performed in the UK annually and they are usually performed in adults over the age of 65. As such, it can be a risky operation with high chance of developing complications, including death, especially if there is frailty before the operation. Such patients are much more susceptible to infections or to have complications, such as wound breakdown, because of poor healing. Whilst some patients might be frail from the outset, surgery can cause patients to become frail ('surgical frailty'). This can happen in all age groups, not just the elderly and is not uncommon after an EmLap.

This study aims to establish blood tests (biomarkers) associated with frailty, explore the ability of frailty markers measured before EmLAP to predict death after EmLAP, define changes in frailty in EmLAP patients and analyse the influence of frailty on quality of life post EmLAP.

Over 2 years, 150 patients age ≥40 undergoing EmLAP in a hospital will be recruited and followed up for 90 days looking at different frailty markers. These include (a)blood tests (biomarkers) analysed in a special laboratory machine called mass spectrometer to identify chemical markers linked to frailty status (b)CT scan looking at muscle bulk (sarcopenia) (c)Rockwood Clinical Frailty Score, a scoring system assessing how much a patient can do (1 is fit; 9 is extremely frail).

The investigators hope that these results will improve our understanding of frailty and lead to further research to improve outcomes for EmLAP patients.

Clinical Trial Description

Over 30,000 emergency laparotomies (EmLAP) are performed in the UK annually yet research in EmLAP is sparse. The largest UK national observational cohort study (Emergency Laparotomy and frailty study, ELF) found higher rates of 30 and 90-day mortality as well as higher post-operative complications in the frail patients. These findings were reflected in the National Emergency Laparotomy Audit (NELA) 7th report and the results have worsened.

Frailty is a clinical syndrome of increased vulnerability that results from ageing associated multi-system physiological decline resulting in reduction of the individual's ability to cope with physiological stress such as surgery. Frailty can be identified using different assessments but due to practicality in emergency setting, the Rockwood Clinical Frailty Score (CFS) is increasingly used and has been incorporated in NELA. Frailty is not unique to the older EmLAP population, it is also present in 16% of adults aged 40 to 65 years. If frailty pre-EmLAP is prevalent, then it must be remembered that surgery can induce frailty in non-frail patients and worsening frailty in those that were already frail (surgical frailty).

Overall, there is lack of understanding in the biochemical aetiology of frailty. Early detection of subclinical changes and changes at the molecular level are key to enhancing our understanding of the biology of frailty and ultimately improving patients outcomes. This study aims to establish blood based biomarkers that could identify frailty objectively in EmLAP patients. The secondary aims are to compare preoperative frailty markers in their ability to predict 30 and 90-day mortality post-EmLAP, define perioperative changes in frailty in patients undergoing EmLAP and analyse the influence of perioperative frailty on morbidity and quality of life post- EmLAP.

Methods A prospective single centred observational study will be conducted over on 150 patients ≥40 years of age that undergo EmLAP over 2years. Patients will be included according to the established NELA criteria. The variables collected include demographics, co-morbidities using, polypharmacy, lifestyle, place of residence, indication and type of surgery (as per NELA criteria) and prognostic NELA score.

The frailty markers will be collected preoperatively and post- operatively day 1 and 7:

1. Blood sample for mass spectrometry analysis (additional blood tube on top of routine bloods)

2. Preoperative CT abdomen pelvis

3. Malnutrition Universal Screening Tool (MUST) score (recorded on admission)

4. Abbreviated Mental Test (AMT) score (recorded on admission)

5. Routine serum biochemistry and haematology: Hb, White cells, C- Reactive protein, Albumin

6. Rockwood Clinical Frailty Score (CFS). Score 1 -9 with frail as ≥4.

Other follow-up data collection:

1. Day 30 and 90 mortality assessed from medical records

2. Place of residence post discharge following EmLAP

3. Day 30 and 90 blood samples for mass spectrometry analysis

4. 30 day morbidity (according Clavien Dindo classification)

5. Total hospital stay including critical care stay

6. Day 30 and 90 quality of life post EmLAP using EQ5D-5L.

The frailty markers will be compared between groups of frail and non-frail patients using statistical methods such as regression model and adjust for appropriate confounding variables. ;

Related Conditions & MeSH terms

• Emergencies
• Frailty
• Sarcopenia
• Surgery

• NCT number: NCT05416047
• Study type: Observational
• Source: NHS Greater Glasgow and Clyde
• Status: Recruiting
• Start date: May 30, 2022
• Completion date: August 1, 2024