Patient Satisfaction With Postoperative Follow up After Minimally Invasive Hysterectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Minimally Invasive Surgery, Hysterectomy, Postoperative, Satisfaction

Intervention / Treatment
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* Other: postoperative follow up appointment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Two and six week follow up<br>Patients will be assigned to routine two and six week postoperative follow up appointments | Other: postoperative follow up appointment<br>* Comparison of two and six week postoperative follow up versus a six week postoperative follow up alone<br>|
| Experimental: Six week follow up only<br>Patients will be assigned to a single six week postoperative follow up appointment | Other: postoperative follow up appointment<br>* Comparison of two and six week postoperative follow up versus a six week postoperative follow up alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | To assess patient satisfaction with the number of postoperative follow up office visits after minimally invasive hysterectomy for benign indications utilizing the Surgical Care - Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician & Group Survey. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication rate | Determine the type and number of postoperative complications as assessed using the Clavien-Dindo Classification system has been selected as a validated and objective measure to collect data pertaining to postoperative complications | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hysterectomy, minimally invasive surgery, gynecology, satisfaction