A Real-world Study to Examine the Relationship Between Simple Physical Functioning Tests, Complications and Recovery Following Abdominal Surgery.

NCT ID: NCT03930784

Last Updated: 2019-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-21

Study Completion Date

2017-07-06

Brief Summary

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Background: Complications impact physical and psychological recovery and are associated with financial cost. General physical function has not been studied in relation to the development of surgical complications in this cohort.

Objective: Evaluate the physical function performance differences between those who develop complications and those who do not and determine their impact on recovery.

Design: Observational Setting: The pre-operative assessment unit in the University Hospital Limerick. Patients: Forty-nine participants who were planned to undergo abdominal surgery were recruited \& 43 completed the study.

Main outcome measure: Demographics, physical function, lung function, surgical parameters, complications and recovery data was collected.

Detailed Description

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Conditions

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Surgery--Complications Abdomen Physical Activity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants

Divided for analysis as having suffered post-operative complications or not

Nil intervention

Intervention Type OTHER

Interventions

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Nil intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Written consent to participate in the study
* Eighteen years or above
* Planned for elective abdominal surgery
* American Society of Anaesthesia physical status score \<4.

Exclusion Criteria

* Abdominal surgery within one year prior to study entry
* Unable or unwilling to give informed consent
* Inability (cognitive) to perform the pre-operative tests, as characterised by inability to understand the information in the patient information leaflet
* Current systemic acute illness
* Scheduled for non-abdominal surgery
* Unstable angina or myocardial infarction in the previous month
* Physical limitation precluding inability to participate in pre-operative tests.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Dublin, Trinity College

OTHER

Sponsor Role collaborator

University Hospital of Limerick

OTHER

Sponsor Role lead

Responsible Party

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mary flahive

Senior Physiotherapist, Practice Tutor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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043/16

Identifier Type: -

Identifier Source: org_study_id

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