Accelerated Enhanced RECOVERy Following Minimally Invasive Colorectal Cancer Surgery (RecoverMI)

March 14, 2022 updated by: M.D. Anderson Cancer Center

The goal of this clinical research study is to learn if RecoverMI care can help to shorten the time that patients are in the hospital after surgery and if it can help them recover sooner.

RecoverMI includes the following parts:

  • Preoperative Education
  • Early oral intake
  • Early mobilization
  • Telemedicine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one group is the same, better, or worse than the other group.

  • If you are assigned to Group 1, you will receive standard enhanced care after your surgery.
  • If you are assigned to Group 2, you will receive routine care after surgery, but you will also receive accelerated recovery, early discharge, and Telemedicine. Participants will be loaned an iPad to use for video-conferencing and text messaging in this study.

This is an investigational study. The study doctor can explain how RecoverMI is designed to work.

Up to 32 participants will be enrolled in this study. All will take part at MD Anderson.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient has histologically proven colorectal cancer or polyp(s) that is planned to be treated by surgical resection performed with curative intent.
  2. Patient is >/= 18 years and younger than 80 years.
  3. Elective minimally invasive operation.
  4. No planned ostomy creation at time of enrollment.
  5. Serum creatinine <1.5 measured within 30 days of surgery.
  6. Ability to speak, read, and understand English.

Exclusion Criteria:

  1. Strong, self-reported history of postoperative nausea and vomiting.
  2. History of congestive heart failure. Systolic heart failure defined as Ejection Fraction (EF) </= 40%), or diastolic heart failure defined as EF >40% PLUS systemic manifestation of heart failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care Arm
Standard enhanced care following minimally invasive colorectal cancer surgery
Behavioral: Standard Enhanced Care
Experimental: Intervention (RecoverMI) Arm
Routine care with Accelerated Recovery Plan, Early Discharge, and Telemedicine following minimally invasive colorectal cancer surgery
Other: Telemedicine
Behavioral: Accelerated Recovery Plan
Behavioral: Early Discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative Hospital Length of Stay (LOS)
Time Frame: 30 days post transplant
30 days post transplant

Secondary Outcome Measures

Outcome Measure
Time Frame
Failure Rate (FR) in the RecoverMI Arm
Time Frame: 30 days
30 days
Patient Satisfaction
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

American Society of Colon and Rectal Surgeons

Investigators

  • Principal Investigator: George Chang, MD, MS, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2016

Primary Completion (Actual)

March 8, 2022

Study Completion (Actual)

March 8, 2022

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0583
  • NCI-2016-00742 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe