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Trial record 6 of 3497 for:    Louisville

Patient Satisfaction With Postoperative Follow up After Minimally Invasive Hysterectomy

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ClinicalTrials.gov Identifier: NCT03642743
Recruitment Status : Not yet recruiting
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Shan Biscette, University of Louisville

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.

Condition or disease Intervention/treatment Phase
Minimally Invasive Surgery Hysterectomy Postoperative Satisfaction Other: postoperative follow up appointment Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Estimated Study Start Date : August 20, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: Two and six week follow up
Patients will be assigned to routine two and six week postoperative follow up appointments
Other: postoperative follow up appointment
Comparison of two and six week postoperative follow up versus a six week postoperative follow up alone

Experimental: Six week follow up only
Patients will be assigned to a single six week postoperative follow up appointment
Other: postoperative follow up appointment
Comparison of two and six week postoperative follow up versus a six week postoperative follow up alone




Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Postoperative complication rate [ Time Frame: 6 weeks ]
    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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642743


Contacts
Contact: Sherree Goss, RN 1-502-588-4333 skgoss01@louisville.edu
Contact: Nkiruka Chbua, MD 1-415-516-9739 n0chub01@louisville.edu

Locations
United States, Kentucky
Health Care Outpatient Center and University of Louisville Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Sherree Goss, RN    502-588-4333    skgoss01@louisville.edu   
Principal Investigator: Shan Biscette, MD         
Sub-Investigator: Traci Ito, MD         
Sub-Investigator: Nkiruka Chuba, MD         
Sub-Investigator: Resad Pasic, MD, PhD         
Sub-Investigator: Xiaohong Liu, MD         
Sub-Investigator: Cesta Megan, MD         
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Shan Biscette, MD University of Louisville School of Medicine

Additional Information:
Publications of Results:

Responsible Party: Shan Biscette, Associate Professor of Gynecology, University of Louisville
ClinicalTrials.gov Identifier: NCT03642743     History of Changes
Other Study ID Numbers: 18.0481
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shan Biscette, University of Louisville:
hysterectomy
minimally invasive surgery
gynecology
satisfaction