Frailty and Sarcopenia Outcomes in Emergency General Surgery

NCT03534765 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 294

Last updated 2019-01-10

No results posted yet for this study

Summary

1. A retrospective scoping cohort review of adult patients undergoing emergency laparotomy/laparoscopy for acute gastrointestinal (GI) pathology who have had a CT scan of the abdomen(+/- pelvis). CT measured sarcopenia would be compared with clinical outcomes, 30-day and 1-year mortality.
2. A prospective observational cohort study and bio-banking exercise of routinely collected clinical data, in a cohort of patient undergoing emergency laparotomy/laparoscopy or conservative treatment for an otherwise operable pathology. An interrogation of CT measured sarcopenia and a validated clinical frailty score would be analysed against clinical outcomes, 30-day and 1-year mortality.

The investigators aim to research the association and predictive advantage of combining subjectively measured frailty, objectively measured CT sarcopenia and other risk predicting tools used in every day surgical practice and surgical outcomes (mortality and morbidity) in a cohort of acute surgical patients undergoing surgery or conservative treatment.

Conditions

  • Frail Elderly Syndrome
  • Emergencies
  • Surgery
  • Sarcopenia

Interventions

DIAGNOSTIC_TEST

CT abdomen +/- pelvis

Diagnostic CT scan (only if requested by responsible clinicians)

DIAGNOSTIC_TEST

Edmunton Frailty Score

Patient completed previously valided questionnaire quantifying frailty.

PROCEDURE

Emergency laparotomy for general surgical pathology

Emergency general surgical laparotomy (defined by the UK NELA body)

Sponsors & Collaborators

  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER
  • Basingstoke and North Hampshire Hospital

    collaborator UNKNOWN
  • Dorset County Hospital NHS Foundation Trust

    collaborator OTHER_GOV
  • Poole Hospital NHS Foundation Trust

    collaborator OTHER
  • Portsmouth Hospitals NHS Trust

    collaborator OTHER_GOV
  • Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

    collaborator OTHER_GOV
  • Salisbury NHS Foundation Trust

    collaborator OTHER_GOV
  • University of Southampton

    collaborator OTHER
  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV
  • Hampshire Hospitals NHS Foundation Trust

    collaborator OTHER
  • Isle of Wight NHS Trust

    collaborator OTHER
  • Yeovil District Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Malcolm West, MD PhD MRCS · University of Southampton

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-03-31
Completion
2020-08-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03534765 on ClinicalTrials.gov