Clinical trial NCT03642743: Patient Satisfaction With Postoperative Follow up After Minimally Invasive Hysterectomy
Official title: Patient Satisfaction With Two and Six Week Postoperative Follow up Appointments After Benign Minimally Invasive Hysterectomy Versus Two Week Postoperative Visit Alone: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Minimally Invasive Surgery
Hysterectomy
Postoperative
Satisfaction
Keywords: hysterectomy
minimally invasive surgery
gynecology
satisfaction
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 174
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This prospective, randomized control trial will evaluate patient satisfaction with the number of postoperative follow up visits after minimally invasive hysterectomy for the treatment of non-cancerous conditions at an urban academic hospital in Louisville, Kentucky. Patients will be randomized to receive either a two and six week postoperative follow up visits versus a postoperative follow up visit at six weeks alone.

Detailed description: The objective of follow up appointments following benign gynecologic surgery is to ensure adequate postoperative recovery, assess additional patient concerns, and to identify and manage any delayed postoperative complications. There is limited literature addressing short-term postoperative follow up for benign gynecologic surgery, particularly those performed through a minimally invasive approach.

The benefits of minimally invasive surgery includes shorter operative time, reduced hospital stay, improved cosmesis, and faster recovery especially when combined with enhanced recovery after surgery (ERAS) protocols. However, this does not negate the need for follow up. Although no consensus exists on the appropriate frequency and number of postoperative appointments, there is no debate on its value.

Due to lack of evidence on this issue, the number and frequency of postoperative appointments is currently dependent on surgeon preference, type of procedure performed and complications encountered intraoperatively and postoperatively, which could lead to patient confusion and unnecessary cost and hassle.

For this reason, investigation of outcomes based on the number and frequency of postoperative follow up visits may improve optimal patient satisfaction, improve compliance and provide early detection of postoperative complications. Such knowledge could serve to mitigate efforts to develop and implement protocols to improve compliance with postoperative follow-up care, potentially reduce emergency room visits, readmissions, empower patients and reduce cost.

Eligibility criteria: Inclusion Criteria:

* Patients of University of Louisville gynecology providers age 18-70 who are planning to undergo a minimally invasive hysterectomy for benign indications.
* Incident surgery must be performed at the University of Louisville Hospital (or affiliated hospital attended by a provider affiliated with the academic department).

Exclusion Criteria:

* Patients with decreased mental capacity who are unable to consent.
* Patients who do not have sufficient English proficiency to complete or understand informed consent for the surgery or study questionnaires.
* Patients with unreliable access to a telephone.
* Patients with significant medical comorbidities that would necessitate more frequent follow up.
* Patients for whom the planned number of follow ups have been pre-determined at the pre-operative visit due to a certain medical need or condition.
* Patients who report an inability to comply with postoperative follow up in either group to which they could be randomized.
* Women who decide at their preoperative visit they do not desire or cannot undergo benign gynecologic surgery as scheduled.
* Women who have medical contraindication to undergoing the benign gynecologic surgery that was planned prior, as determined in their best interest by their provider

Primary outcomes:
measure: Patient satisfaction
timeFrame: 6 weeks
Secondary outcomes:
measure: Postoperative complication rate
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Health Care Outpatient Center and University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville School of Medicine
name: Shan Biscette, MD
role: PRINCIPAL_INVESTIGATOR
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