Perioperative Optimization With Enhanced Recovery

Not Applicable

Active, not recruiting

• Conditions: Complication of Surgical Procedure
• Interventions: Behavioral: POWER

• Registration Number: NCT04504266
• Lead Sponsor: Stanford University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-07
• Study Start: 2020-08-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 368

Inclusion Criteria

• major abdominal surgery in 3+ weeks
• English or Spanish speaking

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Exclusion Criteria

• Unable to use smartphone

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehab	POWER	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.

Primary Outcome Measures

Name	Time	Method
Surgical Complications occurring in the 90 day post-operative period, measured by the comprehensive complication index	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).

Secondary Outcome Measures

Name	Time	Method
Change in 6 minute walk test	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	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.

Trial Locations

Locations (1)

Stanford Health Care; 🇺🇸 Stanford, California, United States