Accelerated Enhanced RECOVERy Following Minimally Invasive Colorectal Cancer Surgery (RecoverMI)
NCT ID: NCT02613728
Last Updated: 2022-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2016-05-13
2022-03-08
Brief Summary
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RecoverMI includes the following parts:
* Preoperative Education
* Early oral intake
* Early mobilization
* Telemedicine
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard of Care Arm
Standard enhanced care following minimally invasive colorectal cancer surgery
Standard Enhanced Care
Intervention (RecoverMI) Arm
Routine care with Accelerated Recovery Plan, Early Discharge, and Telemedicine following minimally invasive colorectal cancer surgery
Accelerated Recovery Plan
Early Discharge
Telemedicine
Interventions
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Accelerated Recovery Plan
Early Discharge
Telemedicine
Standard Enhanced Care
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
79 Years
ALL
No
Sponsors
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American Society of Colon and Rectal Surgeons
OTHER
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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George Chang, MD, MS
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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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.
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2016-00742
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-0583
Identifier Type: -
Identifier Source: org_study_id
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