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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Colorectal Cancer

Treatments: Behavioral: Early Discharge; Other: Telemedicine; Behavioral: Accelerated Recovery Plan; Behavioral: Standard Enhanced Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02613728

2015-0583

NCI-2016-00742 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Standard of Care Arm

Active Comparator group

Description:

Standard enhanced care following minimally invasive colorectal cancer surgery

Treatment:

Behavioral: Standard Enhanced Care

Intervention (RecoverMI) Arm

Experimental group

Description:

Routine care with Accelerated Recovery Plan, Early Discharge, and Telemedicine following minimally invasive colorectal cancer surgery

Treatment:

Behavioral: Early Discharge

Other: Telemedicine

Behavioral: Accelerated Recovery Plan