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

Not Applicable

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT02613728
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-24
• Study Start: 2016-05-13
• Status Verified: 2022-03
• Primary Completion: 2022-03-08
• Study Completion: 2022-03-08
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cumulative Hospital Length of Stay (LOS)	30 days post transplant

Secondary Outcome Measures

Name	Time	Method
Failure Rate (FR) in the RecoverMI Arm	30 days
Patient Satisfaction	30 days

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States