Perioperative Optimization With Enhanced Recovery

Complication of Surgical Procedure Clinical Trial

— POWER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04504266
• Other study ID #: 51827
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 14, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 368
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• major abdominal surgery in 3+ weeks

• English or Spanish speaking

Exclusion Criteria:

• Unable to use smartphone

Related Conditions & MeSH terms

• Complication of Surgical Procedure

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Stanford Health Care	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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