Colorectal SurgeryNCT03237897
Evaluation of a Preoperative Education Class for Colorectal Surgery Patients
An observational study of Colorectal Surgery, run by Wake Forest University Health Sciences.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Preoperative education class and Pedometer
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include only patients scheduled to undergo colorectal surgical procedures at CMC-Main.
Who may be able to join
- Scheduled to undergo surgical operations of the colon or rectum at Carolinas Medical Center Main
Who cannot join
- 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.
About this study
The purpose of the study is to evaluate the value and effectiveness of a newly-implemented preoperative education class for patients undergoing colorectal surgery.
Read the 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.
- Conditions
- Colorectal Surgery
- Being tested
- Preoperative education class, Pedometer
- Keywords
- ERAS, Enhanced recovery after surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative education classBehavioural
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.
PedometerBehavioural
A pedometer will be affixed to patients in the immediate postoperative period and removed at time of discharge
| Study group | Role | What they receive |
|---|---|---|
| Class attendees | A cohort of patients who are scheduled to undergo colorectal surgical procedures and attend the preoperative education class. Patients will be affixed with a pedometer in the postoperative period until discharge. Receives: Behavioral: Preoperative education class; Behavioral: Pedometer | |
| Class non-attendees | A cohort of patients who are scheduled to undergo colorectal surgical procedures and do not attend the scheduled preoperative education class. Patients will be affixed with a pedometer in the postoperative period until discharge. Receives: Behavioral: Pedometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from time of surgery until the time of first documented ambulation, assessed up to 90 days
Mean number of steps
mean number of steps taken daily as measured by pedometer
Measured: from time of surgery until the time of discharge, up to 90 days
Secondary outcomes (5)
Knowledge level
Knowledge level assessed by knowledge survey administered to patients
Measured: 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)
Patient anxiety level
Patient anxiety level assessed by anxiety survey administered to patients
Measured: date of enrollment and date of discharge, up to 90 days following surgery
Patient satisfaction score
Patient satisfaction score assessed by satisfaction survey administered to patients
Measured: date of first postoperative follow-up appointment, up to 90 days following surgery
30-day readmission rate
Measured: 30 days following surgery
Inpatient length of stay
Inpatient length of stay measured in number of days
Measured: from date of surgery until the date of discharge, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study startApr 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionNov 2019 (estimated)
Why it stopped: Study withdrawn due to staff unavailability and limited resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline E Reinke, MD, Principal investigator, Carolinas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237897
- Sponsor's protocol ID
- 07-16-05E
- Status last verified
- Mar 2018
- First submitted
- 23 Sep 2016
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Preoperative Education Class for Colorectal Surgery Patients
- ClinicalTrials.gov ID
- NCT03237897
- Acronym / sponsor ID
- 07-16-05E
- Conditions
- Colorectal Surgery
- Keywords
- ERAS, Enhanced recovery after surgery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to staff unavailability and limited resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Class attendees | – | Behavioral: Preoperative education class, Behavioral: PedometerA cohort of patients who are scheduled to undergo colorectal surgical procedures and attend the preoperative education class. Patients will be affixed with a pedometer in the postoperative period until discharge. |
| Class non-attendees | – | Behavioral: PedometerA cohort of patients who are scheduled to undergo colorectal surgical procedures and do not attend the scheduled preoperative education class. Patients will be affixed with a pedometer in the postoperative period until discharge. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include only patients scheduled to undergo colorectal surgical procedures at CMC-Main.
Key inclusion criteria (1 listed)
- Scheduled to undergo surgical operations of the colon or rectum at Carolinas Medical Center Main
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative education classThe 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. | Behavioural | Class attendees |
| PedometerA pedometer will be affixed to patients in the immediate postoperative period and removed at time of discharge | Behavioural | Class attendees, Class non-attendees |
Primary outcome
Time to ambulation
Time frame: from time of surgery until the time of first documented ambulation, assessed up to 90 days
time to first ambulation following surgery measured by pedometer and notations made by nursing staff in the patient records prior to patient discharge.
Mean number of steps
Time frame: from time of surgery until the time of discharge, up to 90 days
mean number of steps taken daily as measured by pedometer
5 secondary outcomes
Knowledge level
Time frame: 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)
Patient anxiety level
Time frame: date of enrollment and date of discharge, up to 90 days following surgery
Patient satisfaction score
Time frame: date of first postoperative follow-up appointment, up to 90 days following surgery
30-day readmission rate
Time frame: 30 days following surgery
Inpatient length of stay
Time frame: from date of surgery until the date of discharge, up to 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Colorectal Surgery
Not yet recruiting
Tailored Nutrition vs. Exercise Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingPhase 2
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline E Reinke, MD principal investigator
Carolinas Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Surgery, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to ambulation (time frame: from time of surgery until the time of first documented ambulation, assessed up to 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.