The aim 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…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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 outcome
Postoperative data < 30 days
• Length of hospital stay: continuous variable, measured in days
• Complications - major: ordinal variable, Clavien Dindo Classification of
surgical complications (III-V)
• Complications - minor: ordinal variable, Clavien Dindo Classification of
surgical complications (I-II)
• Overall morbidity within the first 30 days postoperative
• Reoperations: dichotomous variable, Yes/No
• Readmission <30 days: dichotomous variable, Yes/No
• In-hospital mortality: dichotomous variable, Yes/No
Gastrointestinal
• Tolerate solid food: continuous variable, measured in days until tolerate
solid food
• Absence of nausea: continuous variable, measured in days until absence of
nausea
• Passage of first flatus: continuous variable, measured in days until first
flatus
• Passage of first stool: continuous variable, measured in days until first
stool
• Weight - preoperative: continuous variable, measured in kilograms
• Weight - at discharge: continuous variable, measured in kilograms
Activity
• Mean preoperative physical activity: continuous variable, measured as a mean
of steps per day during 1 week preoperative
• Postoperative physical activity: continuous variable, daily measured amount
of steps per day until 3 weeks postoperative
• Fatigue: measured with the multidimensional fatigue inventory (Dutch: MVI-20)
consisting of ordinal variables
Pain
• Perceived pain daily postoperative - discharge: continuous variable, daily
measured post-operatively until discharge the visual analogue scale (VAS) 0-10
• Compliance with intake of (pain) medication: dichotomous variable, Yes/No
PROMS
• General quality of life: measured with the EQ-5D-5L questionnaire consisting
of ordinal variables
• Gastro-intestinal quality of life: measured with the GIQLI questionnaire
consisting of ordinal variables
• Physical Activity: measured with the short International Physical Activity
Questionnaire (Dutch: INTERNATIONALE LICHAMELIJKE ACTIVITEITEN VRAGENLIJST)
consisting of continuous variables
• Patient satisfaction questionnaire: measured with a self-developed patient
satisfaction questionnaire consisting of ordinal variables.
Background summary
Perioperative 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.
Study objective
The aim 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.
Study design
Multicentre randomized controlled trial
Intervention
The intervention in this study is a mobile application offering the ERAS-care
pathway in a new way to patients undergoing colorectal surgery. The use of the
application should enhance compliance to selected elements of the ERAS
protocol. Based on the date of surgery, a timeline is generated within the
application. Information or activities from the ERAS protocol will become
available in the application when relevent. They are brought to the user's
attention with pushnotifications. Besides informing patients and motivating
them to participate in their own care pathway, the app has a function in
registering study outcomes, because after an item has been brought to the
attention of the user, feedback is requested throug the application.
Study burden and risks
Both the control group as well as the intervention group will receive care
conform the current standard. The only difference is the use of the app within
the intervention group, therefore no additional risks are associated with
participation in this trial. Burden of participation is restricted to the
completion of four different questionnaires.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Individuals scheduled to undergo colorectal surgery due to: Inflammatory bowel
disease, or colorectal cancer
Adults >18 years of age
Possession of a smartphone operated with iOS 9.0 and up or Android 8.0 and up
Exclusion criteria
Palliative surgery or surgery with additional radio- or chemotherapy
Severe comorbidity which could complicate the postoperative course
Patients with a Karnofsky score <=40
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63874.018.17 |
| OMON | NL-OMON29410 |