Accelerated Enhanced RECOVERy Following Minimally Invasive Colorectal Cancer Surgery (RecoverMI)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Accelerated Recovery Plan
Early Discharge
Telemedicine
Standard Enhanced Care
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal cancer, Colorectal cancer surgery, Polyp(s), Accelerated Enhanced Recovery, RecoverMI, Fluid diary, Questionnaires, Surveys, RecoverMI device
Eligibility Criteria
Inclusion Criteria:
- Patient has histologically proven colorectal cancer or polyp(s) that is planned to be treated by surgical resection performed with curative intent.
- Patient is >/= 18 years and younger than 80 years.
- Elective minimally invasive operation.
- No planned ostomy creation at time of enrollment.
- Serum creatinine <1.5 measured within 30 days of surgery.
- Ability to speak, read, and understand English.
Exclusion Criteria:
- Strong, self-reported history of postoperative nausea and vomiting.
- 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.
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care Arm
Intervention (RecoverMI) Arm
Arm Description
Standard enhanced care following minimally invasive colorectal cancer surgery
Routine care with Accelerated Recovery Plan, Early Discharge, and Telemedicine following minimally invasive colorectal cancer surgery
Outcomes
Primary Outcome Measures
Cumulative Hospital Length of Stay (LOS)
Secondary Outcome Measures
Failure Rate (FR) in the RecoverMI Arm
Patient Satisfaction
Full Information
NCT ID
NCT02613728
First Posted
November 23, 2015
Last Updated
March 14, 2022
Sponsor
M.D. Anderson Cancer Center
Collaborators
American Society of Colon and Rectal Surgeons
1. Study Identification
Unique Protocol Identification Number
NCT02613728
Brief Title
Accelerated Enhanced RECOVERy Following Minimally Invasive Colorectal Cancer Surgery (RecoverMI)
Official Title
Accelerated Enhanced RECOVERy Following Minimally Invasive Colorectal Cancer Surgery (RecoverMI)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 13, 2016 (Actual)
Primary Completion Date
March 8, 2022 (Actual)
Study Completion Date
March 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
American Society of Colon and Rectal Surgeons
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal cancer, Colorectal cancer surgery, Polyp(s), Accelerated Enhanced Recovery, RecoverMI, Fluid diary, Questionnaires, Surveys, RecoverMI device
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care Arm
Arm Type
Active Comparator
Arm Description
Standard enhanced care following minimally invasive colorectal cancer surgery
Arm Title
Intervention (RecoverMI) Arm
Arm Type
Experimental
Arm Description
Routine care with Accelerated Recovery Plan, Early Discharge, and Telemedicine following minimally invasive colorectal cancer surgery
Intervention Type
Behavioral
Intervention Name(s)
Accelerated Recovery Plan
Intervention Type
Behavioral
Intervention Name(s)
Early Discharge
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Type
Behavioral
Intervention Name(s)
Standard Enhanced Care
Primary Outcome Measure Information:
Title
Cumulative Hospital Length of Stay (LOS)
Time Frame
30 days post transplant
Secondary Outcome Measure Information:
Title
Failure Rate (FR) in the RecoverMI Arm
Time Frame
30 days
Title
Patient Satisfaction
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has histologically proven colorectal cancer or polyp(s) that is planned to be treated by surgical resection performed with curative intent.
Patient is >/= 18 years and younger than 80 years.
Elective minimally invasive operation.
No planned ostomy creation at time of enrollment.
Serum creatinine <1.5 measured within 30 days of surgery.
Ability to speak, read, and understand English.
Exclusion Criteria:
Strong, self-reported history of postoperative nausea and vomiting.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Chang, MD, MS
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31216065
Citation
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.
Results Reference
derived
PubMed Identifier
28729319
Citation
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.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
Accelerated Enhanced RECOVERy Following Minimally Invasive Colorectal Cancer Surgery (RecoverMI)
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