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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Telemedicine; Behavioral: Standard Enhanced Care; Behavioral: Accelerated Recovery Plan; Behavioral: Early Discharge

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: Telemedicine; Behavioral: Accelerated Recovery Plan; Behavioral: Early Discharge

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: American Society of Colon and Rectal Surgeons
• Investigators: Principal Investigator: George Chang, MD, MS, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• Bednarski BK, Nickerson TP, You YN, Messick CA, Speer B, Gottumukkala V, Manandhar M, Weldon M, Dean EM, Qiao W, Wang X, Chang GJ. Randomized clinical trial of accelerated enhanced recovery after minimally invasive colorectal cancer surgery (RecoverMI trial). Br J Surg. 2019 Sep;106(10):1311-1318. doi: 10.1002/bjs.11223. Epub 2019 Jun 19.
• Price BA, Bednarski BK, You YN, Manandhar M, Dean EM, Alawadi ZM, Bryce Speer B, Gottumukkala V, Weldon M, Massey RL, Wang X, Qiao W, Chang GJ. Accelerated enhanced Recovery following Minimally Invasive colorectal cancer surgery (RecoverMI): a study protocol for a novel randomised controlled trial. BMJ Open. 2017 Jul 20;7(7):e015960. doi: 10.1136/bmjopen-2017-015960.

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2016
• Primary Completion (Actual): March 8, 2022
• Study Completion (Actual): March 8, 2022

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal cancer; Questionnaires; Surveys; Colorectal cancer surgery; Polyp(s); Accelerated Enhanced Recovery; RecoverMI; Fluid diary; RecoverMI device
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2015-0583; NCI-2016-00742 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No