Surgery--ComplicationsNCT03930784
A Real-world Study to Examine the Relationship Between Simple Physical Functioning Tests, Complications and Recovery Following Abdominal Surgery.
An observational study of Surgery--Complications and Abdomen, run by University Hospital of Limerick.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications, Abdomen, Physical Activity
- What is being tested?
- Nil intervention
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2016to 6 Jul 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants scheduled to under-go elective abdominal surgery
Who may be able to join
- Written consent to participate in the study
- Eighteen years or above
- Planned for elective abdominal surgery
- American Society of Anaesthesia physical status score <4.
Who cannot join
- 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.
About this study
Official title: A Real-world Study to Examine the Relationship Between Simple Physical Functioning Tests, Complications and Recovery Following Abdominal Surgery - a Prospective Cohort Study
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.
Read more
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.
- Conditions
- Surgery--Complications, Abdomen, Physical Activity
- Being tested
- Nil intervention
- Keywords
- physical function, recovery, abdominal
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nil interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Participants | Divided for analysis as having suffered post-operative complications or not Receives: Other: Nil intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with complications & changes over time points.
Defined as occuring within the first 30 days post-operatively using the Clavien Dindo classification
Measured: (1) 0-29 days, (2) 30 and (3) 60 days post operatively
Secondary outcomes (7)
Spirometry to measure lung function
Spirometry was performed to obtain the participant's vital capacity, forced vital capacity, forced expiratory pressure in one second ratio and peak expiratory flow rate.
The instructions and methods used were as per the American Thoracic Society Guidelines 2005. Testing required participants to perform two different tests, three times each. In the initial test, participants were seated and instructed to inhale as deeply as possible before blowing into the spirometer until they felt they needed to inhale again. The second test required them to be seated and after a maximal inhalation, to exhale as forcefully as they could until they felt the need to inhale again. Results were recorded numerically and as a percentage compared to norms of the same sex, race, age, and height. This data was generated by the spirometer (Vitalograph Model 2120 Hand Held REF 79XXX) post testing.
Measured: 2-4 weeks pre-operatively
Peak Cough Flow to measure cough strength
This was performed by attaching a naso-oral mask to a peak flow meter (Mini- Wright Peak Flow Meter, Clement Clarke International). Figure 2.5. Participants were requested to inhale maximally, in a seated position, prior to placing the mask over their nose and mouth, and coughing forcefully. This was repeated three times to give numerical scores. The highest score was recorded. New face masks and flow meters were used for each patient. Results were recorded in litres per minute (L/min). The researcher attempted to limit any reliability bias by using standardised instructions and corrections as required.
Measured: 2-4 weeks pre-operatively
Six Minute Walk Test to measure exercise capacity
This was performed as per the ATS guidelines 2002, as recommended by Biccard 2005. Participants were instructed to walk up and down a thirty-metre distance, over a six-minute period, and each length was recorded. The thirty-metre distance was measured with each metre marked, and the same area used for each test. If they were not at a start or endpoint at the six-minute mark, the distance that they had covered was recorded. Predicted distance was calculated against normative data based on age, sex, weight and height. Participants peak oxygen uptake (VO2Peak) was also calculated as per Ross et al 2010.
Measured: 2-4 weeks pre-operatively
Thirty Second Sit to Stand Test to measure endurance
Participants were asked to go from a seated to standing position and vice versa, as many times as possible in thirty seconds, without the use of their hands to assist. The same standard height chair (17 inches) was used throughout which was placed against a wall for safety. Participants were instructed by the researcher when to start and stop, using a standard stopwatch. When the clock reached thirty seconds, if they were more than half way to a full stand, this was regarded as a stand.Results were recorded as numerical data.
Measured: 2-4 weeks pre-operatively
Grip strength.
Grip strength was recorded, using a Baseline hydraulic hand held dynamometer, as a measure of overall physical function, independent of lower limb strength.Participants were asked to squeeze the dynamometer maximally for a period of 3 seconds, the result was recorded and the test repeated twice more. An average of the scores was recorded in pounds (lbs).
Measured: 2-4 weeks pre-operatively
Change over time in activity levels.
This data was collected by the researcher using the short form International Physical Activity Questionnaire (IPAQ) which is a self-reported measure of activity levels in the previous seven days (IPAQ Research Committee 2005). The IPAQ incorporates questions relating to vigorous and moderate activities, as-well as walking and sitting time. It uses patient subjective reports to quantify the time spent, if any, doing the previously mentioned activities in the previous week. The patients weekly metabolic equivalents (METS) were then calculated using the formula and descriptors provided in the scoring protocol.Sedentary time was calculated in weekly minutes by multiplying their daily minutes answers by seven.
Measured: (1) 2-4 weeks pre-operatively, (2) 30 and (3) 60 days post operatively
Changes in perceived recovery over time
Participants were asked to self-assess their own physical recovery using the same questions and classification as used in a study by Onerupp et al 2015.
Measured: 30 and 60 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start21 Sep 2016
- Primary completion6 Jul 2017
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dublin, Trinity College
- Responsible party
- Principal investigator, mary flahive, University Hospital of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930784
- Sponsor's protocol ID
- 043/16
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2019
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study to Examine the Relationship Between Simple Physical Functioning Tests, Complications and Recovery Following Abdominal Surgery - a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03930784
- Acronym / sponsor ID
- 043/16
- Conditions
- Surgery--Complications, Abdomen, Physical Activity
- Keywords
- physical function, recovery, abdominal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University Hospital of LimerickUniversity, hospital or other
- Collaborators
- University of Dublin, Trinity College
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 29 Apr 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Nil interventionDivided for analysis as having suffered post-operative complications or not |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants scheduled to under-go elective abdominal surgery
Key inclusion criteria (4 listed)
- Written consent to participate in the study
- Eighteen years or above
- Planned for elective abdominal surgery
- American Society of Anaesthesia physical status score <4.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nil intervention | Other | Participants |
Primary outcome
Number of participants with complications & changes over time points.
Time frame: (1) 0-29 days, (2) 30 and (3) 60 days post operatively
Defined as occuring within the first 30 days post-operatively using the Clavien Dindo classification
7 secondary outcomes
Spirometry to measure lung function
Time frame: 2-4 weeks pre-operatively
Peak Cough Flow to measure cough strength
Time frame: 2-4 weeks pre-operatively
Six Minute Walk Test to measure exercise capacity
Time frame: 2-4 weeks pre-operatively
Thirty Second Sit to Stand Test to measure endurance
Time frame: 2-4 weeks pre-operatively
Grip strength.
Time frame: 2-4 weeks pre-operatively
Change over time in activity levels.
Time frame: (1) 2-4 weeks pre-operatively, (2) 30 and (3) 60 days post operatively
Changes in perceived recovery over time
Time frame: 30 and 60 days post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery--Complications and Abdomen, run by University Hospital of Limerick.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with complications & changes over time points. (time frame: (1) 0-29 days, (2) 30 and (3) 60 days post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2019.