FrailtyNCT05416047
An Investigation of Frailty Markers and Outcomes in Patients Requiring Emergency Laparotomy
An observational study of Frailty and Surgery, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Surgery, Sarcopenia
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 May 2022to 1 Aug 2024
- Phase
- Observational
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing emergency laparotomy in Royal Alexandra Hospital
Who may be able to join
- Over 40 years of age
- NELA/ ELLSA inclusion criteria:
- Open, laparoscopic, or laparoscopically-assisted procedures
- Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction
- Washout/evacuation of intra-peritoneal abscess (unless due to appendicitis or cholecystitis - excluded, see below)
- Washout/evacuation of intra-peritoneal haematoma
Show all 11Show fewer
- Bowel resection/repair due to incarcerated incisional, umbilical, inguinal and femoral hernias (but not hernia repair without bowel resection/repair). E.g. Large incisional hernia repair with bowel resection Bowel resection/repair due to obstructing/ incarcerated incisional hernias provided the presentation and findings were acute. This will include large incisional hernia repair with division of adhesions.
- Laparotomy/laparoscopy with inoperable pathology (e.g. peritoneal/hepatic metastases) where the intention was to perform a definitive procedure. This does not include purely diagnostic procedures.
- Laparoscopic/Open Adhesiolysis
- Return to theatre for repair of substantial dehiscence of major abdominal wound (i.e. "burst abdomen")
- Any reoperation/return to theatre for complications of elective general/upper GI surgery meeting the criteria above is included. Returns to theatre for complications following non-GI surgery are now excluded (see exclusion criteria below).
Who cannot join
- Under 40 years of age
- CT scan or postoperative finding of inoperable disseminated peritoneal disease
- Open and close laparotomy (postoperative palliation, non-survivable global ischemia where there are <90cm from duodenojejunal junction to stoma)
- Complication from colonic stenting requiring laparotomy
- NELA exclusion criteria:
- Elective laparotomy / laparoscopy
Show all 23Show fewer
- Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if no procedure is performed because of inoperable pathology, then include)
- Appendicectomy +/- drainage of localised collection unless the procedure is incidental to a non-elective procedure on the GI tract
- Cholecystectomy +/- drainage of localised collection unless the procedure is incidental to a non-elective procedure on the GI tract (All surgery involving the appendix or gallbladder, including any surgery relating to complications such as abscess or bile leak is excluded. The only exception to this is if carried out as an incidental procedure to a more major procedure. There might be extreme cases of peritoneal contamination, but total exclusion avoids subjective judgement calls about severity of contamination.)
- Non-elective hernia repair without bowel resection or division of adhesions
- Minor abdominal wound dehiscence unless this causes bowel complications requiring resection.
- Non-elective formation of a colostomy or ileostomy as either a trephine or a laparoscopic procedure (NB: if a midline laparotomy is performed, with the primary procedure being formation of a stoma then this should be included)
- Vascular surgery, including abdominal aortic aneurysm repair
- Caesarean section or obstetric laparotomies
- Gynaecological laparotomy
- Ruptured ectopic pregnancy, or pelvic abscesses due to pelvic inflammatory disease
- Laparotomy/laparoscopy for pathology caused by blunt or penetrating trauma
- All surgery relating to organ transplantation (including returns to theatre for any reason following transplant surgery)
- Surgery relating to sclerosing peritonitis
- Surgery for removal of dialysis catheters
- Laparotomy/laparoscopy for oesophageal pathology
- Laparotomy/laparoscopy for pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract
- Returns to theatre for complications (eg bowel injury, haematoma, collection) following non-GI surgery are now excluded. i.e returns to theatre following renal, urological, gynaecological, vascular, hepatic, pancreatic, splenic surgery are excluded
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Alexandra Hospital
Paisley, Renfrewshire, PA2 9PN
Hwei Jene Ng, 01413146965, hweijene.ng@ggc.scot.nhs.uk
Susan Moug, susan.moug@ggc.scot.nhs.uk
About this study
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.
Read more
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.
Read the detailed 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:
- Blood sample for mass spectrometry analysis (additional blood tube on top of routine bloods)
- Preoperative CT abdomen pelvis
- Malnutrition Universal Screening Tool (MUST) score (recorded on admission)
- Abbreviated Mental Test (AMT) score (recorded on admission)
- Routine serum biochemistry and haematology: Hb, White cells, C- Reactive protein, Albumin
- Rockwood Clinical Frailty Score (CFS). Score 1 -9 with frail as ≥4.
Other follow-up data collection:
- Day 30 and 90 mortality assessed from medical records
- Place of residence post discharge following EmLAP
- Day 30 and 90 blood samples for mass spectrometry analysis
- 30 day morbidity (according Clavien Dindo classification)
- Total hospital stay including critical care stay
- 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.
- Conditions
- Frailty, Surgery, Sarcopenia
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Frail and no frail | Frailty will be assessed using Rockwood Clinical Frailty Score | |
| Sarcopenia and no sarcopenia | Sarcopenia will be assessed using psoas muscle mass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative frailty markers
Recruited patients will be categorised into frail and non- frail group according to collected data on co-morbidities, CT measurement for sarcopenia, Rockwood CFS and frailty questionnaires results. Biomarker identified on mass spectrometry will be compared with result from patient grouping of frail and non- frail.
Measured: 30 days
Secondary outcomes (2)
Perioperative changes on 30- day morbidity, 30-day and 90-day mortality
Data on length of total hospital stay, length of stay in critical care, post operative complications according to Clavien Dindo Classification, time from surgery to medical discharge (i.e. when medically well, excluding social issues etc), date and cause of death within 90 days post operative will be collected and compared among frail and non- frail group of patients.
Measured: 90 days
Influence of perioperative frailty on quality of life post emergency laparotomy
Changes in quality of life post EmLAP and place of residence post discharge will be explored using EQ5D-5L questionnaire on day 30 and 90 post operative
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start30 May 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Strathclyde
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416047
- Sponsor's protocol ID
- GN20SG508
- Status last verified
- Jun 2022
- First submitted
- 17 May 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ng HJ, Rattray NJW, Quasim T, Moug SJ. Changes in frailty status and discharge destination post emergency laparotomy. World J Emerg Surg. 2025 Apr 25;20(1):37. doi: 10.1186/s13017-025-00612-8.
PubMed 40281633Ng HJ, Quasim T, Rattray NJW, Moug S. Investigation of frailty markers including a novel biomarker panel in emergency laparotomy: protocol of a prospective cohort study. BMC Surg. 2023 Jul 5;23(1):190. doi: 10.1186/s12893-023-02093-5.
PubMed 37408022
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Frailty Markers and Outcomes in Patients Requiring Emergency Laparotomy
- ClinicalTrials.gov ID
- NCT05416047
- Acronym / sponsor ID
- GN20SG508
- Conditions
- Frailty, Surgery, Sarcopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Strathclyde
- Study start
- 30 May 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 13 Jun 2022 (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.
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.
Detailed 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:
- Blood sample for mass spectrometry analysis (additional blood tube on top of routine bloods)
- Preoperative CT abdomen pelvis
- Malnutrition Universal Screening Tool (MUST) score (recorded on admission)
- Abbreviated Mental Test (AMT) score (recorded on admission)
- Routine serum biochemistry and haematology: Hb, White cells, C- Reactive protein, Albumin
- Rockwood Clinical Frailty Score (CFS). Score 1 -9 with frail as ≥4.
Other follow-up data collection:
- Day 30 and 90 mortality assessed from medical records
- Place of residence post discharge following EmLAP
- Day 30 and 90 blood samples for mass spectrometry analysis
- 30 day morbidity (according Clavien Dindo classification)
- Total hospital stay including critical care stay
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frail and no frail | – | –Frailty will be assessed using Rockwood Clinical Frailty Score |
| Sarcopenia and no sarcopenia | – | –Sarcopenia will be assessed using psoas muscle mass |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing emergency laparotomy in Royal Alexandra Hospital
Key inclusion criteria (11 listed)
- Over 40 years of age
- NELA/ ELLSA inclusion criteria:
- Open, laparoscopic, or laparoscopically-assisted procedures
- Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction
- Washout/evacuation of intra-peritoneal abscess (unless due to appendicitis or cholecystitis - excluded, see below)
Key exclusion criteria (23 listed)
- Under 40 years of age
- CT scan or postoperative finding of inoperable disseminated peritoneal disease
- Open and close laparotomy (postoperative palliation, non-survivable global ischemia where there are <90cm from duodenojejunal junction to stoma)
- Complication from colonic stenting requiring laparotomy
- NELA exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preoperative frailty markers
Time frame: 30 days
Recruited patients will be categorised into frail and non- frail group according to collected data on co-morbidities, CT measurement for sarcopenia, Rockwood CFS and frailty questionnaires results. Biomarker identified on mass spectrometry will be compared with result from patient grouping of frail and non- frail.
2 secondary outcomes
Perioperative changes on 30- day morbidity, 30-day and 90-day mortality
Time frame: 90 days
Influence of perioperative frailty on quality of life post emergency laparotomy
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Derived from this study: PubMed 40281633Ng HJ, Rattray NJW, Quasim T, Moug SJ. Changes in frailty status and discharge destination post emergency laparotomy. World J Emerg Surg. 2025 Apr 25;20(1):37. doi: 10.1186/s13017-025-00612-8.
- Derived from this study: PubMed 37408022Ng HJ, Quasim T, Rattray NJW, Moug S. Investigation of frailty markers including a novel biomarker panel in emergency laparotomy: protocol of a prospective cohort study. BMC Surg. 2023 Jul 5;23(1):190. doi: 10.1186/s12893-023-02093-5.
- Individual participant dataSharing planned: No
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Surgery, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 11 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 28 Apr 2023. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative frailty markers (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05416047, which also lists 2 linked publications.
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 28 Apr 2023.