Perioperative Optimization With Enhanced Recovery

NCT ID: NCT04504266

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-14

Study Completion Date

2024-12-31

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.

Detailed Description

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Conditions

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Complication of Surgical Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control Arm

Recommendations to follow Mediterranean diet and exercise regularly before surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Prehab

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.

Group Type EXPERIMENTAL

POWER

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unable to use smartphone
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Cindy Kin

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cindy Kin, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Brendan Visser, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Health Care

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37848690 (View on PubMed)

Other Identifiers

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51827

Identifier Type: -

Identifier Source: org_study_id

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