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A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery

A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery: A Randomized Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03277053
Enrollment
104
Registered
2017-09-08
Start date
2016-08-24
Completion date
2017-12-01
Last updated
2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Disorders

Keywords

colorectal, laparoscopic, application, ERP, adherence, mobile

Brief summary

A randomized control trial on patients undergoing laparoscopic colorectal resection in an Enhanced Recovery Program (ERP). The intervention is delivered via an electronic application containing guidelines, information, and tailored feedback. The hypothesis is that the application will improve adherence to the ERP.

Detailed description

Introduction: Enhanced Recovery Programs (ERP) in colorectal surgery reduce postoperative morbidity and shorten length of hospital stay with no increase in readmission rates. However, poor adherence to ERP elements remains a challenge. Recent studies suggest that the use of mobile device applications has the potential to improve patient compliance with treatment guidelines. We recently developed and pilot tested a mobile app to support an ERP for colorectal surgery which collects patient-reported recovery information and engages patients as stakeholders in their recovery process. The overall aim of this study is to estimate the extent to which the use of this mobile device app impacts adherence to postoperative ERP elements in comparison to standard preoperative education. Methods. The proposal is for a two-group, assessor-blind, randomized trial including adult patients with colorectal diseases planned for surgical resection. Participants will be randomly assigned into one of two groups: 1. usual perioperative education and audit, or 2. a mobile device application for postoperative education and self-audit. The intervention will be delivered through a tablet present at the bedside with an application which links education, recovery planning, and daily self-assessment to a plan of care. It educates patients about daily recovery milestones and track their adherence. The primary outcome will be patient adherence to postoperative enhanced recovery elements. Other targeted outcomes include self-reported recovery, satisfaction and patient activation. According to an a priori power analysis, a sample of 104 patients (52 per group) is targeted for this trial. Significance: This study will contribute evidence regarding the use of mobile device technology for education and the direct involvement of patients as stakeholders in postoperative recovery. The study findings have the potential to increase patient engagement in the care pathway, which has the potential to increase compliance to pathway elements and improve postoperative outcomes.

Interventions

DEVICEMobile application

A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway. Contains information, guidelines, questionnaires and feedback

OTHERControl.

Patient receive an ipad with no application.

Sponsors

Society of American Gastrointestinal and Endoscopic Surgeons
CollaboratorOTHER
Dr. Liane S. Feldman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* elective laparoscopic colorectal resection. * Proficient in english or french

Exclusion criteria

* intellectual disabilities * major simultaneous procedures

Design outcomes

Primary

MeasureTime frameDescription
Completion of 5 patient-dependent pathway interventions that involve patient participation on the initial 48 hrs after surgery.postoperative day 2Questionnaire including 5 pathway interventions that involve patient participation during the first 48 hours after surgery (mobilization, gum chewing, consumption of oral liquids, breathing exercises, nutritional supplement).

Secondary

MeasureTime frameDescription
Length of stayone monthNumber of days spent in the hospital after surgery
Complicationsone monthComprehensive complication index (CCI)
Successful Recoverypostoperative day 4Discharge by postoperative day 4 with no complications.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026