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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613728
• Other study ID #: 2015-0583
• Secondary ID: NCI-2016-00742
• Status: Completed
• Phase: N/A
• Start date: May 13, 2016
• Est. completion date: March 8, 2022

Study information

• Verified date: March 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 8, 2022
• Est. primary completion date: March 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Accelerated Recovery Plan

• Early Discharge

Other:
• Telemedicine

Behavioral:
• Standard Enhanced Care

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	American Society of Colon and Rectal Surgeons

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Hospital Length of Stay (LOS)		30 days post transplant
Secondary	Failure Rate (FR) in the RecoverMI Arm		30 days
Secondary	Patient Satisfaction		30 days

External Links

•   University of Texas MD Anderson Cancer Center Website