Complication of Surgical ProcedurePOWERNCT04504266
Perioperative Optimization With Enhanced Recovery
A study testing POWER in people with Complication of Surgical Procedure, run by Stanford University at 1 site in United States.
Trial summary
This is a randomized controlled trial examining the effect of a motivational interview and perioperative mobile-app based nutrition and exercise intervention on surgical outcomes. The hypothesis is that such an intervention will improve surgical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Surgical Procedure
- What is being tested?
- POWER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2020to 31 Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- major abdominal surgery in 3+ weeks
- English or Spanish speaking
Who cannot join
- Unable to use smartphone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Optimization With Enhanced Recovery: The Effect of Health Habits on Surgical Outcomes in Patients Undergoing Major Abdominal Operations
This is a randomized controlled trial examining the effect of a motivational interview and perioperative mobile-app based nutrition and exercise intervention on surgical outcomes. The hypothesis is that such an intervention will improve surgical outcomes. Patients who are planned to undergo major elective abdominal surgery will be randomized to standard care or the nutrition/exercise intervention. This intervention consists of a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery.
- Conditions
- Complication of Surgical Procedure
- Being tested
- POWER
- Keywords
- prehabilitation, exercise, nutrition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POWERBehavioural
This intervention consists of a motivational interview and a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Recommendations to follow Mediterranean diet and exercise regularly before surgery. |
| Prehab | Experimental | This intervention consists of a motivational interview and a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery. Receives: Behavioral: POWER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Complications occurring in the 90 day post-operative period, measured by the comprehensive complication index
The comprehensive complication index is an integrated score from 0 to 100 of all complications occurring in a specified time period and their severities as categorized by Clavien-Dindo classification. Calculation of the CCI is via a web-based calculator (www.assessurgery.com).
Measured: 90 days after surgery
Secondary outcomes (1)
Change in 6 minute walk test
Participants will be asked to walk as fast they can for 6 minutes using a validated mobile application (Timed Walk) to measure the distance walked.
Measured: It will take about 6 minutes to assess, and this will be performed at enrollment, right before surgery, and at 30 and 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start14 Aug 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication of Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy Kin, Stanford University
- Investigators
- Cindy Kin, MD, Principal investigator, Stanford UniversityBrendan Visser, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504266
- Sponsor's protocol ID
- 51827
- Acronym
- POWER
- Status last verified
- Mar 2024
- First submitted
- 5 Aug 2020
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kimura C, Liu Y, Crowder SE, Arbaugh C, Mai U, Shankar K, Shelton A, Visser B, Kin C. Barriers and Facilitators of Surgical Prehabilitation Adherence from the Patient Perspective: a Mixed Method Study. J Gastrointest Surg. 2023 Nov;27(11):2547-2556. doi: 10.1007/s11605-023-05857-9. Epub 2023 Oct 17.
PubMed 37848690
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Optimization With Enhanced Recovery: The Effect of Health Habits on Surgical Outcomes in Patients Undergoing Major Abdominal Operations
- ClinicalTrials.gov ID
- NCT04504266
- Acronym / sponsor ID
- POWER / 51827
- Conditions
- Complication of Surgical Procedure
- Keywords
- prehabilitation, exercise, nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Aug 2020 (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.
This is a randomized controlled trial examining the effect of a motivational interview and perioperative mobile-app based nutrition and exercise intervention on surgical outcomes. The hypothesis is that such an intervention will improve surgical outcomes. Patients who are planned to undergo major elective abdominal surgery will be randomized to standard care or the nutrition/exercise intervention. This intervention consists of a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Recommendations to follow Mediterranean diet and exercise regularly before surgery. |
| Prehab | Experimental | Behavioral: POWERThis intervention consists of a motivational interview and a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- major abdominal surgery in 3+ weeks
- English or Spanish speaking
Key exclusion criteria (1 listed)
- Unable to use smartphone
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 |
|---|---|---|
| POWERThis intervention consists of a motivational interview and a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery. | Behavioural | Prehab |
Primary outcome
Surgical Complications occurring in the 90 day post-operative period, measured by the comprehensive complication index
Time frame: 90 days after surgery
The comprehensive complication index is an integrated score from 0 to 100 of all complications occurring in a specified time period and their severities as categorized by Clavien-Dindo classification. Calculation of the CCI is via a web-based calculator (www.assessurgery.com).
1 secondary outcome
Change in 6 minute walk test
Time frame: It will take about 6 minutes to assess, and this will be performed at enrollment, right before surgery, and at 30 and 90 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 37848690Kimura C, Liu Y, Crowder SE, Arbaugh C, Mai U, Shankar K, Shelton A, Visser B, Kin C. Barriers and Facilitators of Surgical Prehabilitation Adherence from the Patient Perspective: a Mixed Method Study. J Gastrointest Surg. 2023 Nov;27(11):2547-2556. doi: 10.1007/s11605-023-05857-9. Epub 2023 Oct 17.
- 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.
Cindy Kin, MD principal investigator
Stanford University
Brendan Visser, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POWER in people with Complication of Surgical Procedure, run by Stanford University 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 1 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: status not confirmed, as of the sponsor's last update on 15 Mar 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?
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?
Surgical Complications occurring in the 90 day post-operative period, measured by the comprehensive complication index (time frame: 90 days after surgery). 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 NCT04504266, which also lists 1 linked publication.
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 15 Mar 2024.