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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Accelerated Recovery Plan
* Behavioral: Early Discharge
* Other: Telemedicine
* Behavioral: Standard Enhanced Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has histologically proven colorectal cancer or polyp(s) that is planned to be treated by surgical resection performed with curative intent. Patient is >/= 18 years and younger than 80 years. Elective minimally invasive operation. No planned ostomy creation at time of enrollment. Serum creatinine <1.5 measured within 30 days of surgery. Ability to speak, read, and understand English. Exclusion Criteria: Strong, self-reported history of postoperative nausea and vomiting. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Colorectal cancer surgery, Polyp(s), Accelerated Enhanced Recovery, RecoverMI, Fluid diary, Questionnaires, Surveys, RecoverMI device