Patient Satisfaction With Postoperative Follow up After Minimally Invasive Hysterectomy
NCT ID: NCT03642743
Last Updated: 2021-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
174 participants
INTERVENTIONAL
2018-08-08
2020-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Two and six week follow up
Patients will be assigned to routine two and six week postoperative follow up appointments
postoperative follow up appointment
Comparison of two and six week postoperative follow up versus a six week postoperative follow up alone
Six week follow up only
Patients will be assigned to a single six week postoperative follow up appointment
postoperative follow up appointment
Comparison of two and six week postoperative follow up versus a six week postoperative follow up alone
Interventions
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postoperative follow up appointment
Comparison of two and six week postoperative follow up versus a six week postoperative follow up alone
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
FEMALE
No
Sponsors
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University of Louisville
OTHER
Responsible Party
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Shan Biscette
Associate Professor of Gynecology
Principal Investigators
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Shan Biscette, MD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville School of Medicine
Locations
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Health Care Outpatient Center and University of Louisville
Louisville, Kentucky, United States
Countries
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References
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Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG. Hysterectomy rates in the United States, 2003. Obstet Gynecol. 2007 Nov;110(5):1091-5. doi: 10.1097/01.AOG.0000285997.38553.4b.
Cohen SL, Ajao MO, Clark NV, Vitonis AF, Einarsson JI. Outpatient Hysterectomy Volume in the United States. Obstet Gynecol. 2017 Jul;130(1):130-137. doi: 10.1097/AOG.0000000000002103.
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Bateman AG, Neilens H, Gericke CA, George J, Freeman RM. Is there a need for postoperative follow-up after routine urogynaecological procedures? Patients will self-present if they have problems. Int Urogynecol J. 2014 Mar;25(3):381-6. doi: 10.1007/s00192-013-2229-1. Epub 2013 Oct 9.
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Agdi M, Al-Ghafri W, Antolin R, Arrington J, O'Kelley K, Thomson AJ, Tulandi T. Vaginal vault dehiscence after hysterectomy. J Minim Invasive Gynecol. 2009 May-Jun;16(3):313-7. doi: 10.1016/j.jmig.2009.01.006. Epub 2009 Mar 14.
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Other Identifiers
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18.0481
Identifier Type: -
Identifier Source: org_study_id
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