Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000540718
Ethics application status
Approved
Date submitted
16/03/2022
Date registered
6/04/2022
Date last updated
1/06/2023
Date data sharing statement initially provided
6/04/2022
Date results information initially provided
1/06/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring outcomes in adults after major abdominal surgery - a mixed methods study.
Scientific title
Exploring functional outcomes, lived experiences, expectations, and beliefs of patients who are three months post major upper abdominal surgery (MUAS) at Royal Perth Hospital in Perth, Western Australia.
Secondary ID [1] 306660 0
Nil known.
Universal Trial Number (UTN)
U1111-1275-6588
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major upper abdominal surgery patients 325601 0
Condition category
Condition code
Physical Medicine / Rehabilitation 322962 322962 0 0
Physiotherapy
Surgery 322963 322963 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Major Upper Abdominal Surgery (MUAS):
Upper abdominal surgery (UAS) is defined as any surgical procedure performed to the abdomen through an incision that is superior to or extends superior to the level of the umbilicus. Upper abdominal surgery involves opening the abdomen in order for a surgeon to examine the contents and, where possible, remedy any pathology. Major upper abdominal surgery (MUAS) is defined as an upper abdominal procedure requiring general anaesthetic for more than one hour and a post-operative hospital length of stay of more than 24 hours. Common pathologies addressed via MUAS include viscus organ perforation, mesenteric ischemia, haemorrhage, cancer-related pathologies, and bowel obstructions. Patients/participants in the study will be under observation for a period of approximately 3 months.

Recruitment
Potential participants were identified by a physiotherapist who is a member of the treating team at Royal Perth Hospital (RPH) on Ward 6G (abdominal surgery ward) immediately following their surgery. A physiotherapist screened for patients meeting inclusion criteria daily and consulted with the medical team to ensure the potential participants were deemed capable of consent.

Participants were approached by a physiotherapist to consent to participate in the study. Two forms of contact were obtained at this point in order to arrange for the three-month follow-up interview.

Method
Participants
Once written informed consent of the participant was obtained, the physiotherapist completed the data collection form. Details on this form include two methods of contacting the patient, the patient’s Clinical Frailty Score (CFS) (this was already calculated as part of routine clinical care) and the Lawton’s instrumental activities of daily living (IADL) scale. Data collection forms were stored in a secure, locked cupboard within the Physiotherapy Department of RPH. At patient discharge the remaining details of the data collection form were completed (length of surgery, surgery procedure, complications during hospital stay, length of hospital stay) by a member of the study team.

Participants were allocated a unique study number. The participant’s name and study number were recorded in a master log. The master log linking the participant details with the unique study number was securely stored at WA Health (W:\ Drive) and was not made available to Curtin University. Data was entered into REDCap (central database) in coded format by the (site) study coordinator.

At three months post surgery, participants were contacted by telephone to arrange an appropriate date and time to have their follow up interview. At the scheduled follow-up interview via phone call, participants completed the post-operative questionnaires which collected the following data: CFS, MoCA Blind test, the Lawton’s IADLs, NPRS and FSS. Participants were also asked if they would like to participate in a seperate interview where a series of open-ended questions regarding their experience during recovery after MUAS will be asked. This interview occurred on a seperate date and time by another researcher and was aimed to take less than 30 minutes.

The data gathered from the questionnaires were entered directly into the REDCap system. Interviews were recorded and transcribed verbatim.

Data integrity and completeness was optimised by making a maximum of 2 follow-up phone calls to participants with missing or incomplete post-operative data. Remaining participants with missing or incomplete data were considered non-responders.

Caregivers
At the second interview involving open-ended questions, the study investigator asked if the primary caregiver of the participant would be willing to partake in the interview. Verbal consent was recorded at this time and a written consent form was mailed with a reply-paid envelope attached to the caregiver to obtain formal written consent. Only when written consent was obtained was information obtained be used. The interviewer asked caregivers about their experiences caring for someone who had undergone MUAS and any burden this placed upon them.

Guiding principles for the interviews
The interviews focused on broad categories, informed by the literature, and comprise open-ended questions exploring functional recovery following surgery. Activities were grouped as basic activities of daily living (e.g. eating, bathing dressing toileting, mobility and grooming) and activities that require more complex planning such as more complex activities such as meal preparation, domestic chores, paying bills and taking medication. Both perceived barriers and enablers to these tasks were sought. A discussion was facilitated on points of disagreement between the participants and caregiver, with clarification sought to understand the nature of these areas of discord in lived experiences. Responses from the participants and caregivers interview transcripts were entered into NVivo10 (QSR International Pty Ltd, version 10, 2012) to facilitate data organisation, coding, and management. Data collection and analyses will be performed concurrently to monitor the emergence of new themes. Inductive thematic analysis will be used to identify codes and themes that reflected participants’ perceptions and experiences. To enhance the trustworthiness of the analysis, individual data and interpretations will be independently reviewed by a second investigator experienced with thematic analysis.

Medical notes information:
In addition to these outcome measures, patients contact details were recorded at the time of consent. At patient discharge, the following data was collected from the medical records: indication for why the surgery is being carried out, pathologies associated with the surgery, emergency or elective status, pre-operative haemoglobin, pre-operative pH level, pre-operative base excess, pre-operative lactate level, Portsmouth-Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSOM) risk score, Australia and New Zealand Emergency Laparotomy Audit (ANZELA) risk score, surgical procedure name, length of surgery, complications during hospital stay and length of hospital stay.

Participant participation:
The process has been practiced and timed and is likely to take approximately 15 minutes for the questionnaires and less than 30 minutes for the patient interview or 15 minutes for the caregiver interview. This will be explained upfront to participants.
Intervention code [1] 323106 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330730 0
Clinical frailty: Clinical frailty was measured using the clinical frailty scale (CFS), a validated scale used to assess frailty and fitness in individuals. It is a 9-point scale, where a score is derived based on clinical judgement, with 1 being very fit, and 9 being terminally ill. A person with a score of 5 or above is considered frail
Timepoint [1] 330730 0
This was collected at the time of consent/recruitment and at the three month follow-up appointment post-surgery.
Primary outcome [2] 330731 0
Level of functional independence with instrumental activities of daily living (IADL's): This was measured using the Lawton`s IADL scale. The Lawton`s IADL scale is a reliable and validated self-rating instrument that assesses independent living skills such as food preparation, house-keeping, and the ability to handle finances, medications, and laundry. The scale is a useful tool to measure deterioration/improvement in function over time
Timepoint [2] 330731 0
This was collected at the time of consent/recruitment as well as at the three month follow-up appointment post-surgery.
Secondary outcome [1] 407361 0
Pain levels: Pain levels were measured using the numerical pain rating scale (NPRS) post-operatively. The NPRS is an 11-point ordinal scale that measures the intensity of pain in adults. The scale ranges from 0 to 10, with 0 representing no pain, and 10 representing the worst pain imaginable. The test-retest reliability of the NPRS has been reported to be between 0.67 and 0.96, making it a reliable tool for measuring post-operative pain in the study`s participants.
Timepoint [1] 407361 0
This was collected at the three-month follow-up appointment post-surgery.
Secondary outcome [2] 407362 0
Fatigue levels: Fatigue levels were measured using the fatigue severity scale (FSS). The FSS consists of 9 items, measuring fatigue severity and interference with functioning. Each item is scored using a Likert-type scale ranging from 1 (“strongly disagree”) to 7 (“strongly agree”). The FSS total scores range from 9 to 63, with scores greater than or equal to 36 suggesting clinically elevated fatigue.
Timepoint [2] 407362 0
This was collected at the three-month follow-up appointment post-surgery..
Secondary outcome [3] 407363 0
Cognitive state: Cognitive state was measured using the Montreal cognitive assessment via telephone (MoCA blind). The MoCA blind is a modified version of the original MoCA with the removal of the two visually presented items. This allows it to be implemented over the telephone making it feasible for this study. It is a valid and reliable instrument used to assess orientation, attention, immediate and delayed recall (memory), language, and abstraction. A total score of 18/22 is considered normal, and a score below 18/22 is suggestive of cognitive impairment.
Timepoint [3] 407363 0
This was collected at the three-month follow-up appointment post-surgery..
Secondary outcome [4] 407364 0
Patient lived experiences: Participants were interviewed, and data was collected on their experiences. Interviews were recorded and transcribed verbatim. The number of participants interviewed was dependent on when no new themes or codes emerge from the data. At this point, data collection stopped and data analysis commenced.
Timepoint [4] 407364 0
Interviews were conducted approximately three-months post-surgery..
Secondary outcome [5] 407365 0
Patient caregiver lived experiences: Caregivers were interviewed, and data was collected on their experiences. Interviews were recorded and transcribed verbatim. The number of caregivers interviewed continued until no new themes or codes emerged from the data. At this point, data collection stopped and data analysis commenced.
Timepoint [5] 407365 0
Interviews of caregivers were conducted approximately three-months post-surgery..

Eligibility
Key inclusion criteria
Participants inclusion criteria:
1) 18 years of age or older.
2) Fluent in written and spoken English.
3) Attending RPH for MUAS, defined as an incision 5cm or longer that extends above the umbilicus and the requirement for general anaesthesia for greater than or equal to 1 hour
4) Anticipated post-operative hospital length of stay of greater than or equal to 24 hours.
5) The medical team deem the patient to be suitable to provide consent

Caregiver inclusion criteria:
1) 18 years of age or older.
2) Fluent in written and spoken English.
3) The primary caregiver of the recruited participant since the participant's procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participant inclusion criteria
1) Documented evidence of a cognitive impairment.
2) Scheduled for an isolated hernia repair.
3) From supported residential care or high-level care.
4) Prior to surgery, inability to ambulate without physical assistance.
5) Unable to be contacted by telephone following hospital discharge

Caregiver exclusion criteria
1) Is being formally paid to care for the participant

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
NUMBER OF PARTICIPANTS (SAMPLE SIZE):
Recruitment for this study took place between March 2022 and May 2022. Sixty-eight potential participants were screened for study eligibility. A total of 33 patients were excluded, and 35 participants were recruited for the study. For the qualitative aspect of the study, patient interviews were conducted until thematic saturation was reached.

METHOD:
Participants
Once written informed consent of the participant was obtained, the physiotherapist completed the data collection form. Details on this form include two methods of contacting the patient, the patient’s Clinical Frailty Score (CFS) (this was already calculated as part of routine clinical care) and the Lawton’s instrumental activities of daily living (IADL) scale. Data collection forms were stored in a secure, locked cupboard within the Physiotherapy Department of RPH. At patient discharge the remaining details of the data collection form were completed (length of surgery, surgery procedure, complications during hospital stay, length of hospital stay) by a member of the study team.

Participants were allocated a unique study number. The participant’s name and study number were recorded in a master log. The master log linking the participant details with the unique study number was securely stored at WA Health (W:\ Drive) and was not made available to Curtin University. Data was entered into REDCap (central database) in coded format by the (site) study coordinator.

At three months post surgery, participants were contacted by telephone to arrange an appropriate date and time to have their follow up interview. At the scheduled follow-up interview via phone call, participants completed the post-operative questionnaires which collected the following data: CFS, MoCA Blind test, the Lawton’s IADLs, NPRS and FSS. Participants were also asked if they would like to participate in a seperate interview where a series of open-ended questions regarding their experience during recovery after MUAS will be asked. This interview occurred on a seperate date and time by another researcher and was aimed to take less than 30 minutes.

The data gathered from the questionnaires were entered directly into the REDCap system. Interviews were recorded and transcribed verbatim.

Data integrity and completeness was optimised by making a maximum of 2 follow-up phone calls to participants with missing or incomplete post-operative data. Remaining participants with missing or incomplete data were considered non-responders.

Caregivers
At the second interview involving open-ended questions, the study investigator asked if the primary caregiver of the participant would be willing to partake in the interview. Verbal consent was recorded at this time and a written consent form was mailed with a reply-paid envelope attached to the caregiver to obtain formal written consent. Only when written consent was obtained was information obtained be used. The interviewer asked caregivers about their experiences caring for someone who had undergone MUAS and any burden this placed upon them.

Guiding principles for the interviews
The interviews focused on broad categories, informed by the literature, and comprise open-ended questions exploring functional recovery following surgery. Activities were grouped as basic activities of daily living (e.g. eating, bathing dressing toileting, mobility and grooming) and activities that require more complex planning such as more complex activities such as meal preparation, domestic chores, paying bills and taking medication. Both perceived barriers and enablers to these tasks were sought. A discussion was facilitated on points of disagreement between the participants and caregiver, with clarification sought to understand the nature of these areas of discord in lived experiences. Responses from the participants and caregivers interview transcripts were entered into NVivo10 (QSR International Pty Ltd, version 10, 2012) to facilitate data organisation, coding, and management. Data collection and analyses will be performed concurrently to monitor the emergence of new themes. Inductive thematic analysis will be used to identify codes and themes that reflected participants’ perceptions and experiences. To enhance the trustworthiness of the analysis, individual data and interpretations will be independently reviewed by a second investigator experienced with thematic analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/03/2022
Date of last participant enrolment
Anticipated
30/09/2022
Actual
18/05/2022
Date of last data collection
Anticipated
31/01/2023
Actual
30/08/2022
Sample size
Target
30
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21960 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 37054 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 310988 0
University
Name [1] 310988 0
Curtin University, School of Allied Health
Country [1] 310988 0
Australia
Funding source category [2] 310997 0
Hospital
Name [2] 310997 0
Physiotherapy Department, Royal Perth Bentley Group
Country [2] 310997 0
Australia
Funding source category [3] 310998 0
Other
Name [3] 310998 0
East Metropolitan Health Service Executive
Country [3] 310998 0
Australia
Primary sponsor type
University
Name
Curtin University (School of Allied Health)
Address
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 312298 0
Hospital
Name [1] 312298 0
Royal Perth Hospital (Physiotherapy Department)
Address [1] 312298 0
Wellington St, Perth WA 6000
Country [1] 312298 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310541 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 310541 0
Wellington St,
Perth
WA 6000
Ethics committee country [1] 310541 0
Australia
Date submitted for ethics approval [1] 310541 0
30/12/2021
Approval date [1] 310541 0
04/01/2022
Ethics approval number [1] 310541 0
RGS0000004684

Summary
Brief summary
There is limited research on the medium-term recovery and outcomes of patients three months following major upper abdominal surgery. The aim of this study was to explore the functional outcomes and lived experiences in adults three months after major upper abdominal surgery at Royal Perth Hospital in Perth, Western Australia. Data collected from the participants prior to their surgery was compared with data collected from them three months after the procedure.. The measures included clinical frailty and functional independence. At three months post-surgery, information regarding abdominal pain, post-surgical fatigue, and cognition were also gathered in order to explore the association between these variables and the participants level of functional recovery three months following the surgery. Qualitative interviews were also conducted at this time to explore the participants lived experiences and those of their primary carer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118018 0
A/Prof Kylie Hill
Address 118018 0
Curtin University
Curtin School of Allied Health
Building 408
Kent St, Bentley WA 6102
Country 118018 0
Australia
Phone 118018 0
+61 892662774
Fax 118018 0
Email 118018 0
k.hill@curtin.edu.au
Contact person for public queries
Name 118019 0
Dr Meg Harrold
Address 118019 0
Curtin University
Curtin School of Allied Health
Building 401
Kent St, Bentley WA 6102
Country 118019 0
Australia
Phone 118019 0
+61 892669228
Fax 118019 0
Email 118019 0
M.Harrold@curtin.edu.au
Contact person for scientific queries
Name 118020 0
Dr Meg Harrold
Address 118020 0
Curtin University
Kent St, Bentley WA 6102
Country 118020 0
Australia
Phone 118020 0
+61 892669228
Fax 118020 0
Email 118020 0
M.Harrold@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data for the primary and secondary outcomes will be available.
When will data be available (start and end dates)?
Data will be available following publication. All data will be kept securely for up to 7 years at Royal Perth Hospital before being destroyed.
Available to whom?
Researchers involved in the study (two Curtin university honours students, the two study principal investigators, the senior physiotherapist at Royal Perth Hospital, and two Royal Perth Hospital recruiting physiotherapists) will have access to the study data. All other access requests will be assessed by the principle investigators.
Available for what types of analyses?
Data analysis was based on achieving the aims in the approved proposal.
Data was made available for meta-analysis on request to the principle investigators
How or where can data be obtained?
Access will be gained from the principal investigators.
Tel: +61 892662774
Email: k.hill@curtin.edu.au


What supporting documents are/will be available?




Results publications and other study-related documents

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