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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06350916
Other study ID # IRB00082594
Secondary ID LCI-GI-CRC-SEAML
Status Completed
Phase
First received
Last updated
Start date January 28, 2021
Est. completion date October 1, 2021

Study information

Verified date April 2024
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate whether patient-centered educational material delivered before and immediately after surgery can help improve outcomes for patients undergoing colorectal surgery.


Description:

To analyze the impact of implementation of patient-centered educational material delivered the SeamlessMD® mobile application on perioperative Enhanced Recovery After Surgery (ERAS) metric completion rates among patients undergoing elective colorectal surgery. This is a non-interventional, prospective feasibility study. The planned study period will encompass adult patients (>18 years) scheduled to undergo an elective colorectal surgery procedure at CMC-Main during the six-month period of December 2020 to May 2021. Patients enrolling in SeamlessMD will be prompted by the mobile app to electronically complete a validated quality-of-life assessment, the Quality of Recovery (QoR-15) evaluation, five days prior to surgery, three days postoperatively, and 30 days postoperatively.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date October 1, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients (>18 years old) - Scheduled to undergo an elective colorectal surgery procedure (for benign or malignant colon or rectal pathology) at CMC-Main by one of the 5 participating colorectal surgeons (Davis, Hill, Kasten, Salo, Squires) - Ability to provide informed consent Exclusion Criteria: - Emergent, non-elective colorectal procedures - Non-English speaking

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SeamlessMD® Mobile Application
Mobile cloud-based applications (apps), such as SeamlessMD®, are readily accessible on smart phones and offer an innovative strategy to encourage and track patient adherence to recommended ERAS components pre- and postoperatively.

Locations

Country Name City State
United States Levine Cancer Institute Charlotte North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences Atrium Health Levine Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perioperative ERAS metric completion rate Completion rate for perioperative ERAS metrics 30 Days Following Hospital Discharge
Primary Postoperative hospital length of stay Postoperative hospital length of stay 30 Days Following Hospital Discharge
Primary Postoperative complications Occurrence of postoperative complications within 30 days, classified as Clavien-Dindo Grade I-V 30 Days Following Hospital Discharge
Primary 30-day readmission Readmission to any hospital facility as inpatient within 30 days of surgery 30 Days Following Hospital Discharge
Secondary Postoperative Opioid Consumption Postoperative opioid consumption in morphine equivalent daily doses (MEDDs) as extracted from the medical administration record (MAR) for the inpatient hospitalization period 30 Days Following Hospital Discharge
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