Perioperative Optimization With Enhanced Recovery

Study Overview
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Brief Summary
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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.

Official Title
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Perioperative Optimization With Enhanced Recovery: The Effect of Health Habits on Surgical Outcomes in Patients Undergoing Major Abdominal Operations

Conditions
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Complication of Surgical Procedure

Intervention / Treatment
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* Behavioral: POWER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: major abdominal surgery in 3+ weeks English or Spanish speaking Exclusion Criteria: Unable to use smartphone

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>Recommendations to follow Mediterranean diet and exercise regularly before surgery. | |
| Experimental: Prehab<br>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. | Behavioral: POWER<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prehabilitation, exercise, nutrition