Accelerated Enhanced RECOVERy Following Minimally Invasive Colorectal Cancer Surgery (RecoverMI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02613728|
Recruitment Status : Active, not recruiting
First Posted : November 24, 2015
Last Update Posted : May 14, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Behavioral: Accelerated Recovery Plan Behavioral: Early Discharge Other: Telemedicine Behavioral: Standard Enhanced Care||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Accelerated Enhanced RECOVERy Following Minimally Invasive Colorectal Cancer Surgery (RecoverMI)|
|Actual Study Start Date :||May 13, 2016|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2021|
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
Behavioral: Accelerated Recovery Plan
Behavioral: Early Discharge
- Cumulative Hospital Length of Stay (LOS) [ Time Frame: 30 days post transplant ]
- Failure Rate (FR) in the RecoverMI Arm [ Time Frame: 30 days ]
- Patient Satisfaction [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613728
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||George Chang, MD, MS||M.D. Anderson Cancer Center|