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Role of Pre-operative Counseling in the Surgical Patient

Role of Pre-operative Counseling in the Surgical Patient

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03925961
Enrollment
6
Registered
2019-04-24
Start date
2019-08-06
Completion date
2020-09-25
Last updated
2021-10-20

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

Conditions

Patient Education

Brief summary

The study will seek to determine if surgical patients do better or the same if participants undergo pre-operative counseling for elective laparoscopic same day surgery. The study hypothesizes that patients who receive a pre-operative education booklet and a phone call from a surgical registered nurse, compared to the current standard of care, will have higher satisfaction with regard to participants' surgical experience, decrease in the number of post-operative phone calls, decrease in the number of opioid medications, and decrease in the number of emergency department visits. The importance of this study is to understand what surgical clinical practices can do in the pre-operative setting to enhance a surgical patient's recovery.

Detailed description

In the last decade there has been an increasing focus on the patient's pre-operative, operative and post operative experience to help patient's in participants' recovery. For example, the surgical community has focused on pathways such as Enhanced Recovery After Surgery (ERAS), to improve patient's outcome and surgical experience. Despite this emphasis, little has been described in the literature as to how surgeons can improve a patient's experience by counseling participants on what participants can expect before, during, and after the surgery.

Interventions

The intervention is focused around providing patients with educational information in the pre-operative setting and determine if this improves patients' surgical experience.

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)

Eligibility

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

Inclusion criteria

* General surgical patients who will undergo same-day laparoscopic ventral hernia, inguinal hernia, and gallbladder surgery at Howard County General Hospital with the general surgery practice at Johns Hopkins Community Physicians.

Exclusion criteria

* Patients less than 18 years of age * Adults who lack the capacity to consent * Pregnant women * Prisoners * Non-English speakers.

Design outcomes

Primary

MeasureTime frameDescription
Difference in patient satisfaction as assessed by a 10-point scale1 yearThe study will compare patient satisfaction scores between the three arms of the study groups to determine if there is a difference in patient satisfaction. It will be based on a scale of 1 to 10, 10 being the most satisfied and 1 being the least.

Secondary

MeasureTime frameDescription
Number of post operative emergency department (ED) visits1 year
Number of cases with post operative respiratory occurrences1 year
Number of cases with post operative Urinary tract occurrences1 year
Number of cases with post operative central nervous system (CNS) occurrences1 year
Number of cases with post operative cardiac occurrences1 year
Number of cases with post operative Wound Occurrence1 year
Number of cases with post operative Return to the OR within 30 days1 year
Number of cases with post operative Readmission1 year
Difference in time spent (in minutes) talking to patients on the phone1 yearThe study will assess if there is a difference in the amount of total time spent talking to patients over the phone.
Difference in post-operative number of opioid tablets used30 daysThe study will assess if there is a difference in the number of opioid tablets used at post operative day 30. For the purposes of this study, study patients will be discharged home with a prescription for oxycodone 5mg.
Number of cases with other unclassified post operative occurrences1 year

Countries

United States

Outcome results

None listed

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