Evaluation of a Preoperative Education Class for Colorectal Surgery Patients

Colorectal Surgery Clinical Trial

Official title:

Evaluation of a Preoperative Education Class for Colorectal Surgery Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03237897
• Other study ID #: 07-16-05E
• Status: Withdrawn
• Start date: April 2018
• Est. completion date: November 2019

Study information

• Verified date: March 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Behavioral:
• Preoperative education class
The preoperative enhanced recovery after surgery education class will be offered twice a week in coordination with anesthesia preoperative appointments to minimize inconvenience for patients. Patients will need to attend only one class. All participants will be offered the class. This class will be one hour in duration and will be taught by a surgical advanced care practitioner familiar with the details of colorectal surgery. The class will include detailed information about preoperative care, intraoperative care, and postoperative care.
• Pedometer
A pedometer will be affixed to patients in the immediate postoperative period and removed at time of discharge

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to ambulation	time to first ambulation following surgery measured by pedometer and notations made by nursing staff in the patient records prior to patient discharge.	from time of surgery until the time of first documented ambulation, assessed up to 90 days
Primary	Mean number of steps	mean number of steps taken daily as measured by pedometer	from time of surgery until the time of discharge, up to 90 days
Secondary	Knowledge level	Knowledge level assessed by knowledge survey administered to patients	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)
Secondary	Patient anxiety level	Patient anxiety level assessed by anxiety survey administered to patients	date of enrollment and date of discharge, up to 90 days following surgery
Secondary	Patient satisfaction score	Patient satisfaction score assessed by satisfaction survey administered to patients	date of first postoperative follow-up appointment, up to 90 days following surgery
Secondary	30-day readmission rate		30 days following surgery
Secondary	Inpatient length of stay	Inpatient length of stay measured in number of days	from date of surgery until the date of discharge, up to 90 days