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ERAS APPtimize: Improving compliance to the ERAS care pathway through improving patient participation by using eHealth


- candidate number28166
- NTR NumberNTR7314
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-nov-2017
- Secondary IDsN/A 
- Public TitleERAS APPtimize: Improving compliance to the ERAS care pathway through improving patient participation by using eHealth
- Scientific TitleImproving Enhanced Recovery After Surgery Protocol Compliance Through Active Patient Participation by Using eHealth: a Randomized Controlled Trial
- ACRONYMERAS APPtimize
- hypothesisThe use of an interactive app during the perioperative period, when undergoing colorectal surgery, will activate and stimulate patients and therefore result in higher compliance to the ERAS-protocol.
- Healt Condition(s) or Problem(s) studiedColorectal surgery
- Inclusion criteria- Individuals scheduled to undergo colorectal surgery due to:
o Inflammatory bowel disease
o Colorectal cancer
- Adults aged >18 years
- Possession of a smartphone operated with iOS 8 and up or Android 4.3 and up
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
- Palliative surgery or surgery with additional radio- or chemotherapy
- Severe comorbidity which could complicate the postoperative course
- Patients with a Karnofsky score ¡Ü40
- Incompetence of understanding the Dutch language
- Visual impairment, unless well corrected with visual aids
- Physical disabilities limiting the use of a mobile application, such as Parkinson¡¯s disease
- When pre-operatively is estimated that following the ERAS protocol postoperative is not feasible
- Multiple organ resection
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2018
- planned closingdate1-dec-2019
- Target number of participants227
- InterventionsMobile APPtimize application.
- Primary outcomeThe primary outcome is the overall compliance to the ERAS protocol measured as a mean of the percentages of the single ERAS protocol elements which patients are actively involved in.
- Secondary outcomePostoperative data < 30 days
Length of hospital stay
Overall morbidity < 30 days
Complications - major
Complications - minor
Reoperations
Readmission <30 days
In-hospital mortality
Gastrointestinal
Tolerate solid food
Absence of nausea
Passage of first flatus
Passage of first stool
Weight - preoperative
Weight - at discharge
Activity
Mean preoperative physical activity
Postoperative physical activity
Fatigue
Pain
Perceived pain daily postoperative - discharge
Compliance with intake of (pain) medication
PROMS
General quality of life
Gastro-intestinal quality of life
Physical Activity
Patient satisfaction
- TimepointsInternvention group:
3 weeks prior to surgery download application
1 week prior to surgery start wearing activity tracker
After 3 weeks post-surgery stop wearing activity tracker
Control group:
1 week prior to surgery start wearing activity tracker
After 3 weeks post-surgery stop wearing activity tracker
- Trial web siteYet to be build
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. M.P. Schijven
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Marc Jansen
- Sponsor/Initiator Academic Medical Center (AMC), Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- Publications
- Brief summaryPerioperative care within colorectal surgery is systematically defined in the ‘Enhanced Recovery After Surgery’ (ERAS) program. This program aims to improve perioperative care in a multimodal way to ensure early but safe release from the hospital. Adequate compliance to the elements of the ERAS protocol is multifactorial with room for improvement through patient involvement, which will enhance the post-operative outcomes such as length of stay in hospital. The aim of this study is to improve compliance to the ERAS protocol. Therefore an application for smartphone will be developed to be used by the patient undergoing colorectal surgery. Objective of this study is to generate evidence that a mobile app can activate and stimulate a patient resulting in improved compliance to the ERAS protocol.
- Main changes (audit trail)
- RECORD9-nov-2017 - 8-jul-2018


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