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

NCT ID: NCT02613728

Last Updated: 2022-03-15

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-13

Study Completion Date

2022-03-08

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Standard of Care Arm

Standard enhanced care following minimally invasive colorectal cancer surgery

Group Type ACTIVE_COMPARATOR

Standard Enhanced Care

Intervention Type BEHAVIORAL

Intervention (RecoverMI) Arm

Routine care with Accelerated Recovery Plan, Early Discharge, and Telemedicine following minimally invasive colorectal cancer surgery

Group Type EXPERIMENTAL

Accelerated Recovery Plan

Intervention Type BEHAVIORAL

Early Discharge

Intervention Type BEHAVIORAL

Telemedicine

Intervention Type OTHER

Interventions

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Accelerated Recovery Plan

Intervention Type BEHAVIORAL

Early Discharge

Intervention Type BEHAVIORAL

Telemedicine

Intervention Type OTHER

Standard Enhanced Care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Society of Colon and Rectal Surgeons

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 31216065 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28729319 (View on PubMed)

Related Links

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http://www.mdanderson.org

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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