Investigation of frailty markers including a novel biomarker panel in emergency laparotomy: protocol of a prospective cohort study.
Clinical Frailty Scale
Emergency laparotomy
Frailty biomarkers
Mass spectrometry
Sarcopenia
Journal
BMC surgery
ISSN: 1471-2482
Titre abrégé: BMC Surg
Pays: England
ID NLM: 100968567
Informations de publication
Date de publication:
05 Jul 2023
05 Jul 2023
Historique:
received:
28
03
2023
accepted:
25
06
2023
medline:
7
7
2023
pubmed:
6
7
2023
entrez:
5
7
2023
Statut:
epublish
Résumé
Emergency laparotomy (EmLAP) is one of the commonest emergency operations performed in the United Kingdom (approximately 30, 000 laparotomies annually). These potentially high-risk procedures can be life changing with frail patients and/ or older adults (≥ 65 years) having the poorest outcomes, including mortality. There is no gold standard of frailty assessment and no clinical chemical biomarkers existing in practice. Early detection of subclinical changes or deficits at the molecular level are essential in improving our understanding of the biology of frailty and ultimately improving patient outcomes. This study aims primarily to compare preoperative frailty markers, including a blood-based biomarker panel, in their ability to predict 30 and 90-day mortality post-EmLAP. The secondary aim is to analyse the influence of perioperative frailty on morbidity and quality of life post-EmLAP. A prospective single centred observational study will be conducted on 150 patients ≥ 40 years of age that undergo EmLAP. Patients will be included according to the established NELA (National Emergency Laparotomy Audit) criteria. The variables collected include demographics, co-morbidities, polypharmacy, place of residence, indication and type of surgery (as per NELA criteria) and prognostic NELA score. Frailty will be assessed using: a blood sample for ultra-high performance liquid chromatography mass spectrometry analysis; preoperative CT abdomen pelvis (sarcopenia) and Rockwood Clinical Frailty Scale (CFS). Patients will be followed up for 90 days. Variables collected include blood samples (at post operative day 1, 7, 30 and 90), place of residence on discharge, morbidity, mortality and quality of life (EQ-5D-5 L). The frailty markers will be compared between groups of frail (CFS ≥ 4) and non-frail using statistical methods such as regression model and adjusted for appropriate confounding factors. This study hypothesises that frailty level changes following EmLAP in frail and non- frail patients, irrespective of age. We propose that non- frail patients will have better survival rates and report better quality of life compared to the frail. By studying the changes in metabolites/ biomarkers in these patients and correlate them to frailty status pre-surgery, this highly novel approach will develop new knowledge of frailty and define a new area of clinical biomolecular research. ClinicalTrials.gov: NCT05416047. Registered on 13/06/2022 (retrospectively registered).
Sections du résumé
BACKGROUND
BACKGROUND
Emergency laparotomy (EmLAP) is one of the commonest emergency operations performed in the United Kingdom (approximately 30, 000 laparotomies annually). These potentially high-risk procedures can be life changing with frail patients and/ or older adults (≥ 65 years) having the poorest outcomes, including mortality. There is no gold standard of frailty assessment and no clinical chemical biomarkers existing in practice. Early detection of subclinical changes or deficits at the molecular level are essential in improving our understanding of the biology of frailty and ultimately improving patient outcomes. This study aims primarily to compare preoperative frailty markers, including a blood-based biomarker panel, in their ability to predict 30 and 90-day mortality post-EmLAP. The secondary aim is to analyse the influence of perioperative frailty on morbidity and quality of life post-EmLAP.
METHODS
METHODS
A prospective single centred observational study will be conducted on 150 patients ≥ 40 years of age that undergo EmLAP. Patients will be included according to the established NELA (National Emergency Laparotomy Audit) criteria. The variables collected include demographics, co-morbidities, polypharmacy, place of residence, indication and type of surgery (as per NELA criteria) and prognostic NELA score. Frailty will be assessed using: a blood sample for ultra-high performance liquid chromatography mass spectrometry analysis; preoperative CT abdomen pelvis (sarcopenia) and Rockwood Clinical Frailty Scale (CFS). Patients will be followed up for 90 days. Variables collected include blood samples (at post operative day 1, 7, 30 and 90), place of residence on discharge, morbidity, mortality and quality of life (EQ-5D-5 L). The frailty markers will be compared between groups of frail (CFS ≥ 4) and non-frail using statistical methods such as regression model and adjusted for appropriate confounding factors.
DISCUSSION
CONCLUSIONS
This study hypothesises that frailty level changes following EmLAP in frail and non- frail patients, irrespective of age. We propose that non- frail patients will have better survival rates and report better quality of life compared to the frail. By studying the changes in metabolites/ biomarkers in these patients and correlate them to frailty status pre-surgery, this highly novel approach will develop new knowledge of frailty and define a new area of clinical biomolecular research.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov: NCT05416047. Registered on 13/06/2022 (retrospectively registered).
Identifiants
pubmed: 37408022
doi: 10.1186/s12893-023-02093-5
pii: 10.1186/s12893-023-02093-5
pmc: PMC10321009
doi:
Substances chimiques
Biomarkers
0
Banques de données
ClinicalTrials.gov
['NCT05416047']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
190Subventions
Organisme : Royal College of Surgeons of Edinburgh
ID : SPPG/21/160
Organisme : Royal College of Surgeons of Edinburgh
ID : SPPG/21/160
Organisme : Royal College of Surgeons of Edinburgh
ID : SPPG/21/160
Organisme : Royal College of Surgeons of Edinburgh
ID : SPPG/21/160
Organisme : Association of Surgeons of Great Britain and Ireland/ GUTS UK
ID : Surgical research award 2022
Organisme : Association of Surgeons of Great Britain and Ireland/ GUTS UK
ID : Surgical research award 2022
Organisme : Association of Surgeons of Great Britain and Ireland/ GUTS UK
ID : Surgical research award 2022
Organisme : Association of Surgeons of Great Britain and Ireland/ GUTS UK
ID : Surgical research award 2022
Organisme : NHS Greater Glasgow and Clyde Endowments Management Committee
ID : CV/BOB/EMC/FEB07
Organisme : NHS Greater Glasgow and Clyde Endowments Management Committee
ID : CV/BOB/EMC/FEB07
Organisme : NHS Greater Glasgow and Clyde Endowments Management Committee
ID : CV/BOB/EMC/FEB07
Organisme : NHS Greater Glasgow and Clyde Endowments Management Committee
ID : CV/BOB/EMC/FEB07
Informations de copyright
© 2023. The Author(s).
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