Expired Study
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Houston, Texas 77030


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

2015-0583


NCT ID:

NCT02613728


Secondary ID:

NCI-2016-00742


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

79 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

M.D. Anderson Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

32


Enrollment Type:

Actual


Overall Contact Information

Official Name:George Chang, MD, MS
Principal Investigator
M.D. Anderson Cancer Center

Study Dates

Start Date:May 13, 2016
Completion Date:May 2021
Completion Type:Anticipated
Primary Completion Date:May 2020
Primary Completion Type:Anticipated
Verification Date:May 2019
Last Changed Date:May 10, 2019
First Received Date:November 23, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Cumulative Hospital Length of Stay (LOS)
Time Frame:30 days post transplant
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Failure Rate (FR) in the RecoverMI Arm
Time Frame:30 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Patient Satisfaction
Time Frame:30 days
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Accelerated Recovery Plan
Arm Name:Intervention (RecoverMI) Arm
Intervention Type:Behavioral
Name:Early Discharge
Arm Name:Intervention (RecoverMI) Arm
Intervention Type:Other
Name:Telemedicine
Arm Name:Intervention (RecoverMI) Arm
Intervention Type:Behavioral
Name:Standard Enhanced Care
Arm Name:Standard of Care Arm

Study Arms

Study Arm Type:Active Comparator
Arm Name:Standard of Care Arm
Description:Standard enhanced care following minimally invasive colorectal cancer surgery
Study Arm Type:Experimental
Arm Name:Intervention (RecoverMI) Arm
Description:Routine care with Accelerated Recovery Plan, Early Discharge, and Telemedicine following minimally invasive colorectal cancer surgery

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:M.D. Anderson Cancer Center
Agency Class:Other
Agency Type:Collaborator
Agency Name:American Society of Colon and Rectal Surgeons

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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