Clinical trial NCT03237897: Evaluation of a Preoperative Education Class for Colorectal Surgery Patients
Official title: Evaluation of a Preoperative Education Class for Colorectal Surgery Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Colorectal Surgery
Keywords: ERAS
Enhanced recovery after surgery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include only patients scheduled to undergo colorectal surgical procedures at CMC-Main.

Brief summary: The purpose of the study is to evaluate the value and effectiveness of a newly-implemented preoperative education class for patients undergoing colorectal surgery.

Detailed description: This is a non-randomized study to be conducted in a cohort of patients who are scheduled to undergo colorectal surgical procedures at Carolinas Medical Center (CMC)-Main. The primary objective of this study is to determine the effect of preoperative education classes on postoperative compliance with mobilization guidelines. Secondary objectives of this study are to evaluate the effect of the preoperative education class on patient knowledge, anxiety, and satisfaction, and postoperative outcomes such as inpatient length of stay, postoperative complications, and 30-day readmission rates. Data will be compared between patients who are scheduled to attend the class and attend and those who are scheduled to attend the class and do not.

Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo surgical operations of the colon or rectum at Carolinas Medical Center Main

Exclusion Criteria:

* A medical condition, laboratory finding, or physical exam finding that precludes participation
* Develop a significant intra- or postoperative complication that precludes or delays participation for longer than 4 weeks; or
* Have anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Primary outcomes:
measure: Time to ambulation
timeFrame: from time of surgery until the time of first documented ambulation, assessed up to 90 days
measure: Mean number of steps
timeFrame: from time of surgery until the time of discharge, up to 90 days
Secondary outcomes:
measure: Knowledge level
timeFrame: date of preoperative education class (up to 2 weeks prior to time of surgery) and date of first postoperative follow-up appointment (up to 90 days following surgery)
measure: Patient anxiety level
timeFrame: date of enrollment and date of discharge, up to 90 days following surgery
measure: Patient satisfaction score
timeFrame: date of first postoperative follow-up appointment, up to 90 days following surgery
measure: 30-day readmission rate
timeFrame: 30 days following surgery
measure: Inpatient length of stay
timeFrame: from date of surgery until the date of discharge, up to 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Carolinas Medical Center
name: Caroline E Reinke, MD
role: PRINCIPAL_INVESTIGATOR
References: