Complication of Surgical ProcedureWWADNCT05211531
Walk With a Doc: Enhanced Recovery Walking Program for Surgical Inpatients and Wellness Program for Surgical Residents
An observational study of Complication of Surgical Procedure and Resident Physicians, run by Richard Perugini at 1 site in United States.
Trial summary
Program studying the number of steps post-operative patients need to take to prevent post-operative complications. Also studying surgical resident wellness program that provides extra time to ambulate with inpatients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complication of Surgical Procedure, Resident Physicians
- What is being tested?
- Measuring number of post-operative steps
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 25 Jun 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Minimally invasive surgery patients who are admitted and undergo surgery at a single tertiary care center.
Who may be able to join
- Post-operative surgical patient with an over 24 hour post-operative stay in the hospital
- Safe to ambulate with/without assistance
Who cannot join
- Unable to ambulate
- Bedbound
Trial locations and contacts
1 site in 1 country.
United States1 site
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Program studying the number of steps post-operative patients need to take to prevent post-operative complications. Also studying surgical resident wellness program that provides extra time to ambulate with inpatients.
Read the detailed description
Program studying the number of steps post-operative patients need to take to prevent post-operative complications. Patients receive a pedometer while inpatient to measure their daily steps, which is recorded in the electronic medical record.
- Being tested
- Measuring number of post-operative steps
- Keywords
- Resident physician wellness, Post-operative walking program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring number of post-operative stepsOther
Measuring the number of post-operative steps that inpatients take.
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of steps
Total number of steps ambulated by the patient as measured by a pedometer
Measured: From index surgery to initial post-operative office visit, up to 3 weeks
30 day Post-operative complications
30 day Post-operative complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Aug 2021
- Primary completion25 Jun 2022
- Study completion25 Jun 2022
Why it stopped: Lead study team member deceased, project not continued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Surgical ProcedureStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Perugini
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Responsible party
- Sponsor-investigator, Richard Perugini, University of Massachusetts, Worcester
- Investigators
- Richard Perugini, MD, Principal investigator, UMASS Memorial Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211531
- Sponsor's protocol ID
- H00019609
- Acronym
- WWAD
- Status last verified
- Sep 2024
- First submitted
- 11 Jan 2022
- Last updated
- 25 Sep 2024
- Results posted
- 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 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walk With a Doc: Enhanced Recovery Walking Program for Surgical Inpatients and Wellness Program for Surgical Residents
- ClinicalTrials.gov ID
- NCT05211531
- Acronym / sponsor ID
- WWAD / H00019609
- Keywords
- Resident physician wellness, Post-operative walking program
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lead study team member deceased, project not continued.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Richard PeruginiUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 25 Jun 2022 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 27 Jan 2022 (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.
Program studying the number of steps post-operative patients need to take to prevent post-operative complications. Also studying surgical resident wellness program that provides extra time to ambulate with inpatients.
Detailed description
Program studying the number of steps post-operative patients need to take to prevent post-operative complications. Patients receive a pedometer while inpatient to measure their daily steps, which is recorded in the electronic medical record.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Minimally invasive surgery patients who are admitted and undergo surgery at a single tertiary care center.
Key inclusion criteria (2 listed)
- Post-operative surgical patient with an over 24 hour post-operative stay in the hospital
- Safe to ambulate with/without assistance
Key exclusion criteria (2 listed)
- Unable to ambulate
- Bedbound
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 |
|---|---|---|
| Measuring number of post-operative stepsMeasuring the number of post-operative steps that inpatients take. | Other | – |
Primary outcome
Total number of steps
Time frame: From index surgery to initial post-operative office visit, up to 3 weeks
Total number of steps ambulated by the patient as measured by a pedometer
30 day Post-operative complications
Time frame: 30 days
30 day Post-operative complications
Results and safety
The study was stopped early (reason given: Lead study team member deceased, project not continued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- 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.
Richard Perugini, MD principal investigator
UMASS Memorial Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Surgical Procedure and Resident Physicians, run by Richard Perugini at 1 site in United States.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was stopped early (reason given: Lead study team member deceased, project not continued.). Results are not available in the source record.
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?
Total number of steps (time frame: From index surgery to initial post-operative office visit, up to 3 weeks). The study lists 2 primary outcomes in all. 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 25 Sep 2024.