Abdominal SurgeryNCT03461497
Development of a Patient-Reported Outcome Measure to Assess Recovery After Abdominal Surgery
An observational study of Abdominal Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 7 sites in 5 countries.
Trial summary
As surgery enters the era of value-based care, it is advocated that postoperative recovery be measured using patient-reported outcomes (PROs) as they provide a mean to incorporate the patient's perspectives and experiences into research and clinical decision-making. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Surgery
- How many people
- 530 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Jul 2016to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient's that have undergone abdominal surgery
Who may be able to join
- Age ≥18 years old
- Abdominal surgery within three days to three months before enrolment
- Fluent in the local language
- Willing and able to provide written informed consent
Who cannot join
- Documented mental impairment
- Palliative care
- Advanced musculoskeletal, neurological, pulmonary or cardiac disorders
- Organ transplantation
- Cesarean section
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
United States2 sites
Cleveland Clinic (Main Campus)
Cleveland, Ohio
Cleveland Clinic Florida
Weston, Florida
Canada2 sites
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Jewish General Hospital
Montreal
About this study
Official title: Value-Based Care in Abdominal Surgery: Measuring Recovery Outcomes That Matter to Patients
As surgery enters the era of value-based care, it is advocated that postoperative recovery be measured using patient-reported outcomes (PROs) as they provide a mean to incorporate the patient's perspectives and experiences into research and clinical decision-making. In abdominal surgery, this is currently precluded by the lack of PRO measures specifically developed and validated in the context of postoperative recovery.
The core goal of this research project is to develop a PRO measure aimed to assess postoperative recovery from the perspective of patients undergoing abdominal surgery. This project complies with the US Food and Drug Administration (FDA) and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines for PRO development and will be conducted in three phases:
Read more
Phase 1: Qualitative interviews with patients to develop a conceptual framework and generate relevant items.
Phase 2: Use of Rasch Analysis for item-reduction and scale formation.
Phase 3: Further assessment of measurement properties based on traditional psychometric methods.
Read the detailed description
OBJECTIVE:
To develop a comprehensive, conceptually relevant and psychometrically sound PRO measure to assess recovery after abdominal surgery.
OUTLINE:
- Phase 1(Conceptual framework and item generation): Semi-structured interviews focusing on patient lived experiences after abdominal surgery will be conducted to derive the "final conceptual framework of recovery after abdominal surgery". The interviews are guided by the "hypothesized conceptual framework" which is based on previous literature and expert input. This phase has a minimal targeted sample of 30 patients. To account for potential cross-cultural differences in recovery experiences, the study is enrolling patients from 4 international sites: McGill University Health Centre (Montreal, Canada), Hospital Sao Paulo (Sao Paulo, Brazil), Vita-Salute San Raffaele Hospital (Milan, Italy), and Hokkaido University Hospital (Sapporo, Japan). Interview audio recordings are transcribed, translated if required, and coded according to ICF (International Classification of Functioning, Disability and Health) domains. Codes for which saturation is reached will comprise the final conceptual framework of recovery. Items reflecting the essence of each domain will be generated and patient understanding of the items will be assessed through cognitive interviews. Items for which no problems have been identified and those successfully revised will be compiled into an item pool to be 'calibrated' in subsequent stages of PRO development.
- Phase 2 (Item selection and scoring- Rasch Analysis): In phase 2, the preliminary item pool generated in phase 1 will undergo refinement using Rasch Measurement Theory (RMT). Based on this analysis, items will be modified or eliminated to ensure that the novel PRO measure fits a linear continuum and produces meaningful scores. A target sample of 100 patients undergoing abdominal surgery will be recruited from three tertiary hospitals in Canada. The participants will complete the preliminary PRO measure at five time points: preoperatively, and on postoperative days (PODs) 1, 7, 30, and 90. Items that fail to fit the Rasch model will be revised or removed.
- Phase 3 (Validation using traditional psychometric methods): Further evaluation of the measurement properties of the novel PRO measure will be conducted using traditional psychometric methods. A total of 600 patients undergoing abdominal surgery will be recruited in five tertiary hospitals in Canada and in the United States. Participants will complete the PRO measure in different timepoints: preoperatively, and on PODs 1-7, 28, 60, and 90. Assessment of psychometric properties will focus on internal consistency, test-retest reliability, measurement error, hypothesis testing construct validity, responsiveness, and criterion validity. Interpretability will be assessed by estimating the minimal important difference (MID) using anchor-based methods.
- Conditions
- Abdominal Surgery
- Keywords
- Patient-Reported Outcome, Patient Outcome Assessment, Questionnaire, Self-Report, Abdominal Surgery, Postoperative Period, Recovery of Function, Psychometrics, Qualitative Research, Patient-Centered
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Cohort | Patients undergoing abdominal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcome Measure (PRO)
PRO measure of recovery after abdominal surgery
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study startJul 2016
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital São Paulo, Brazil, Hokkaido University Hospital, San Raffaele University Hospital, Italy, Cleveland Clinic Florida, The Cleveland Clinic, Jewish General Hospital
- Responsible party
- Principal investigator, Julio F Fiore Jr, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Julio F Fiore Jr, PhD, Principal investigator, McGill University, Department of SurgeryLiane S Feldman, MD, Principal investigator, McGill University, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461497
- Sponsor's protocol ID
- VT 57203
- Status last verified
- Apr 2025
- First submitted
- 2 Mar 2018
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fiore JF Jr, Figueiredo S, Balvardi S, Lee L, Nauche B, Landry T, Mayo NE, Feldman LS. How Do We Value Postoperative Recovery?: A Systematic Review of the Measurement Properties of Patient-reported Outcomes After Abdominal Surgery. Ann Surg. 2018 Apr;267(4):656-669. doi: 10.1097/SLA.0000000000002415.
PubMed 28767559Alam R, Figueiredo SM, Balvardi S, Nauche B, Landry T, Lee L, Mayo NE, Feldman LS, Fiore JF Jr. Development of a patient-reported outcome measure of recovery after abdominal surgery: a hypothesized conceptual framework. Surg Endosc. 2018 Dec;32(12):4874-4885. doi: 10.1007/s00464-018-6242-9. Epub 2018 May 17.
PubMed 29777351Alam R, Montanez J, Law S, Lee L, Pecorelli N, Watanabe Y, Chiavegato LD, Falconi M, Hirano S, Mayo NE, Feldman LS, Fiore JF Jr. Development of a conceptual framework of recovery after abdominal surgery. Surg Endosc. 2020 Jun;34(6):2665-2674. doi: 10.1007/s00464-019-07044-x. Epub 2019 Aug 1.
PubMed 31372888Rajabiyazdi F, Alam R, Pal A, Montanez J, Law S, Pecorelli N, Watanabe Y, Chiavegato LD, Falconi M, Hirano S, Mayo NE, Lee L, Feldman LS, Fiore JF Jr. Understanding the Meaning of Recovery to Patients Undergoing Abdominal Surgery. JAMA Surg. 2021 Aug 1;156(8):758-765. doi: 10.1001/jamasurg.2021.1557.
PubMed 33978692
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value-Based Care in Abdominal Surgery: Measuring Recovery Outcomes That Matter to Patients
- ClinicalTrials.gov ID
- NCT03461497
- Acronym / sponsor ID
- VT 57203
- Conditions
- Abdominal Surgery
- Keywords
- Patient-Reported Outcome, Patient Outcome Assessment, Questionnaire, Self-Report, Abdominal Surgery, Postoperative Period, Recovery of Function, Psychometrics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Hospital São Paulo, Brazil, Hokkaido University Hospital, San Raffaele University Hospital, Italy, Cleveland Clinic Florida, The Cleveland Clinic, Jewish General Hospital
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 12 Mar 2018 (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.
As surgery enters the era of value-based care, it is advocated that postoperative recovery be measured using patient-reported outcomes (PROs) as they provide a mean to incorporate the patient's perspectives and experiences into research and clinical decision-making. In abdominal surgery, this is currently precluded by the lack of PRO measures specifically developed and validated in the context of postoperative recovery.
The core goal of this research project is to develop a PRO measure aimed to assess postoperative recovery from the perspective of patients undergoing abdominal surgery. This project complies with the US Food and Drug Administration (FDA) and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines for PRO development and will be conducted in three phases:
Phase 1: Qualitative interviews with patients to develop a conceptual framework and generate relevant items.
Phase 2: Use of Rasch Analysis for item-reduction and scale formation.
Phase 3: Further assessment of measurement properties based on traditional psychometric methods.
Detailed description
OBJECTIVE:
To develop a comprehensive, conceptually relevant and psychometrically sound PRO measure to assess recovery after abdominal surgery.
OUTLINE:
- Phase 1(Conceptual framework and item generation): Semi-structured interviews focusing on patient lived experiences after abdominal surgery will be conducted to derive the "final conceptual framework of recovery after abdominal surgery". The interviews are guided by the "hypothesized conceptual framework" which is based on previous literature and expert input. This phase has a minimal targeted sample of 30 patients. To account for potential cross-cultural differences in recovery experiences, the study is enrolling patients from 4 international sites: McGill University Health Centre (Montreal, Canada), Hospital Sao Paulo (Sao Paulo, Brazil), Vita-Salute San Raffaele Hospital (Milan, Italy), and Hokkaido University Hospital (Sapporo, Japan). Interview audio recordings are transcribed, translated if required, and coded according to ICF (International Classification of Functioning, Disability and Health) domains. Codes for which saturation is reached will comprise the final conceptual framework of recovery. Items reflecting the essence of each domain will be generated and patient understanding of the items will be assessed through cognitive interviews. Items for which no problems have been identified and those successfully revised will be compiled into an item pool to be 'calibrated' in subsequent stages of PRO development.
- Phase 2 (Item selection and scoring- Rasch Analysis): In phase 2, the preliminary item pool generated in phase 1 will undergo refinement using Rasch Measurement Theory (RMT). Based on this analysis, items will be modified or eliminated to ensure that the novel PRO measure fits a linear continuum and produces meaningful scores. A target sample of 100 patients undergoing abdominal surgery will be recruited from three tertiary hospitals in Canada. The participants will complete the preliminary PRO measure at five time points: preoperatively, and on postoperative days (PODs) 1, 7, 30, and 90. Items that fail to fit the Rasch model will be revised or removed.
- Phase 3 (Validation using traditional psychometric methods): Further evaluation of the measurement properties of the novel PRO measure will be conducted using traditional psychometric methods. A total of 600 patients undergoing abdominal surgery will be recruited in five tertiary hospitals in Canada and in the United States. Participants will complete the PRO measure in different timepoints: preoperatively, and on PODs 1-7, 28, 60, and 90. Assessment of psychometric properties will focus on internal consistency, test-retest reliability, measurement error, hypothesis testing construct validity, responsiveness, and criterion validity. Interpretability will be assessed by estimating the minimal important difference (MID) using anchor-based methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Cohort | – | –Patients undergoing abdominal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient's that have undergone abdominal surgery
Key inclusion criteria (4 listed)
- Age ≥18 years old
- Abdominal surgery within three days to three months before enrolment
- Fluent in the local language
- Willing and able to provide written informed consent
Key exclusion criteria (5 listed)
- Documented mental impairment
- Palliative care
- Advanced musculoskeletal, neurological, pulmonary or cardiac disorders
- Organ transplantation
- Cesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient-Reported Outcome Measure (PRO)
Time frame: 3 years
PRO measure of recovery after abdominal surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Background: PubMed 28767559Fiore JF Jr, Figueiredo S, Balvardi S, Lee L, Nauche B, Landry T, Mayo NE, Feldman LS. How Do We Value Postoperative Recovery?: A Systematic Review of the Measurement Properties of Patient-reported Outcomes After Abdominal Surgery. Ann Surg. 2018 Apr;267(4):656-669. doi: 10.1097/SLA.0000000000002415.
- Background: PubMed 29777351Alam R, Figueiredo SM, Balvardi S, Nauche B, Landry T, Lee L, Mayo NE, Feldman LS, Fiore JF Jr. Development of a patient-reported outcome measure of recovery after abdominal surgery: a hypothesized conceptual framework. Surg Endosc. 2018 Dec;32(12):4874-4885. doi: 10.1007/s00464-018-6242-9. Epub 2018 May 17.
- Background: PubMed 31372888Alam R, Montanez J, Law S, Lee L, Pecorelli N, Watanabe Y, Chiavegato LD, Falconi M, Hirano S, Mayo NE, Feldman LS, Fiore JF Jr. Development of a conceptual framework of recovery after abdominal surgery. Surg Endosc. 2020 Jun;34(6):2665-2674. doi: 10.1007/s00464-019-07044-x. Epub 2019 Aug 1.
- Background: PubMed 33978692Rajabiyazdi F, Alam R, Pal A, Montanez J, Law S, Pecorelli N, Watanabe Y, Chiavegato LD, Falconi M, Hirano S, Mayo NE, Lee L, Feldman LS, Fiore JF Jr. Understanding the Meaning of Recovery to Patients Undergoing Abdominal Surgery. JAMA Surg. 2021 Aug 1;156(8):758-765. doi: 10.1001/jamasurg.2021.1557.
- Individual participant dataSharing planned: Undecided
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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.
Julio F Fiore Jr, PhD principal investigator
McGill University, Department of Surgery
Liane S Feldman, MD principal investigator
McGill University, Department of Surgery
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 7 sites in 5 countries.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada, Brazil, Italy, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Patient-Reported Outcome Measure (PRO) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03461497, which also lists 4 linked publications.
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 13 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.