NCT02613728

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

May 13, 2016

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2022

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

5.8 years

First QC Date

November 23, 2015

Last Update Submit

March 14, 2022

Conditions

Colorectal Cancer

Keywords

Colorectal cancerColorectal cancer surgeryPolyp(s)Accelerated Enhanced RecoveryRecoverMIFluid diaryQuestionnairesSurveysRecoverMI device

Outcome Measures

Primary Outcomes (1)

  • Cumulative Hospital Length of Stay (LOS)

    30 days post transplant

Secondary Outcomes (2)

  • Failure Rate (FR) in the RecoverMI Arm

    30 days

  • Patient Satisfaction

    30 days

Study Arms (2)

Standard of Care Arm

ACTIVE COMPARATOR

Standard enhanced care following minimally invasive colorectal cancer surgery

Behavioral: Standard Enhanced Care

Intervention (RecoverMI) Arm

EXPERIMENTAL

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

Behavioral: Accelerated Recovery PlanBehavioral: Early DischargeOther: Telemedicine

Interventions

Accelerated Recovery PlanBEHAVIORAL
Intervention (RecoverMI) Arm
Early DischargeBEHAVIORAL
Intervention (RecoverMI) Arm
TelemedicineOTHER
Intervention (RecoverMI) Arm
Standard Enhanced CareBEHAVIORAL
Standard of Care Arm

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • 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.

    PMID: 31216065DERIVED

  • 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.

    PMID: 28729319DERIVED

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsPolyps

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • George Chang, MD, MS

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2015

First Posted

November 24, 2015

Study Start

May 13, 2016

Primary Completion

March 8, 2022

Study Completion

March 8, 2022

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations

US(1)