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

NCT05416047 | Unknown

• 1 other identifier: GN20SG508
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Frailty; Surgery; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (2)

• Perioperative changes on 30- day morbidity, 30-day and 90-day mortality

  90 days

• Influence of perioperative frailty on quality of life post emergency laparotomy

  90 days

Study Arms (2)

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing emergency laparotomy in Royal Alexandra Hospital

You may qualify if:

• Over 40 years of age
• 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
• 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")

You may not qualify if:

• 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
• Elective laparotomy / laparoscopy
• 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
• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Strathclyde: collaborator

Study Sites (1)

Royal Alexandra Hospital

Paisley, Renfrewshire, PA2 9PN, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 40281633 DERIVED

• Ng 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.

  PMID: 37408022 DERIVED

MeSH Terms

Conditions

Frailty; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: June 13, 2022
• Study Start: May 30, 2022
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 28, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)