NCT04493710

Brief Summary

Assess the influence of sarcopenia on outcomes of emergency laparotomy in the over 65 age group

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

7.6 years

First QC Date

July 20, 2020

Last Update Submit

October 6, 2020

Conditions

Keywords

surgerylaparotomyemergencysarcopeniafrailtymortalityrisk

Outcome Measures

Primary Outcomes (2)

  • Number of participants who die between zero and thirty days

    Post-operative death

    30 days

  • Number of participants who die between zero and ninety days

    Post-operative death

    90 days

Interventions

Sarcopenia estimationDIAGNOSTIC_TEST

Analysis of pre-existing CT imaging

Eligibility Criteria

Age65 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing emergency laparotomy aged 65 or over

You may qualify if:

  • Patient aged 65 or over having emergency laparotomy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WUTH

Upton, Wirral, CH49 5PE, United Kingdom

RECRUITING

MeSH Terms

Conditions

FrailtyEmergenciesSarcopenia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Officials

  • Conor Magee, MD

    Wirral University Teaching Hospitals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Surgeon

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 30, 2020

Study Start

January 1, 2015

Primary Completion

August 1, 2022

Study Completion

December 1, 2022

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations