Perioperative Optimization With Enhanced Recovery

NCT04504266 | Active Not Recruiting

• 1 other identifier: 51827
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication of Surgical Procedure

Keywords

prehabilitation, exercise, nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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.

Behavioral: POWER

Interventions

POWER BEHAVIORAL

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.

Prehab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to use smartphone

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 37848690 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Cindy Kin, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Brendan Visser, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 7, 2020
• Study Start: August 14, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)