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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02613728
Recruitment Status : Active, not recruiting
First Posted : November 24, 2015
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
American Society of Colon and Rectal Surgeons
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Accelerated Recovery Plan Behavioral: Early Discharge Other: Telemedicine Behavioral: Standard Enhanced Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Accelerated Enhanced RECOVERy Following Minimally Invasive Colorectal Cancer Surgery (RecoverMI)
Actual Study Start Date : May 13, 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


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
Behavioral: Accelerated Recovery Plan
Behavioral: Early Discharge
Other: Telemedicine



Primary Outcome Measures :
  1. Cumulative Hospital Length of Stay (LOS) [ Time Frame: 30 days post transplant ]

Secondary Outcome Measures :
  1. Failure Rate (FR) in the RecoverMI Arm [ Time Frame: 30 days ]
  2. Patient Satisfaction [ Time Frame: 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613728


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
American Society of Colon and Rectal Surgeons
Investigators
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Principal Investigator: George Chang, MD, MS M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02613728     History of Changes
Other Study ID Numbers: 2015-0583
NCI-2016-00742 ( Registry Identifier: NCI CTRP )
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Colorectal cancer
Colorectal cancer surgery
Polyp(s)
Accelerated Enhanced Recovery
RecoverMI
Fluid diary
Questionnaires
Surveys
RecoverMI device
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases