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OpenTrials
Completed

NCT Number: NCT02613728

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

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Accelerated Recovery Plan

Behavioral

Early Discharge

Behavioral

Telemedicine

Other

Standard Enhanced Care

Behavioral

Primary outcomes

  1. Cumulative Hospital Length of Stay (LOS)

    Time frame: 30 days post transplant

Secondary outcomes

  1. Failure Rate (FR) in the RecoverMI Arm

    Time frame: 30 days

  2. Patient Satisfaction

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • American Society of Colon and Rectal Surgeons

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2015
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.