NCT03642743

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 8, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

1.6 years

First QC Date

May 2, 2018

Last Update Submit

April 22, 2021

Conditions

Minimally Invasive SurgeryHysterectomyPostoperativeSatisfaction

Keywords

hysterectomyminimally invasive surgerygynecologysatisfaction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Postoperative complication rate

    6 weeks

Study Arms (2)

Two and six week follow up

EXPERIMENTAL

Patients will be assigned to routine two and six week postoperative follow up appointments

Other: postoperative follow up appointment

Six week follow up only

EXPERIMENTAL

Patients will be assigned to a single six week postoperative follow up appointment

Other: postoperative follow up appointment

Interventions

postoperative follow up appointmentOTHER

Comparison of two and six week postoperative follow up versus a six week postoperative follow up alone

Six week follow up onlyTwo and six week follow up

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Care Outpatient Center and University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (24)

  • 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.

    PMID: 17978124RESULT

  • 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.

    PMID: 28594764RESULT

  • Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.

    PMID: 26264829RESULT

  • Slankamenac K, Graf R, Puhan MA, Clavien PA. Perception of surgical complications among patients, nurses and physicians: a prospective cross-sectional survey. Patient Saf Surg. 2011 Nov 22;5(1):30. doi: 10.1186/1754-9493-5-30.

    PMID: 22107603RESULT

  • 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.

    PMID: 24105409RESULT

  • Bromage SJ, Napier-Hemy RD, Payne SR, Pearce I. Outpatient follow up appointments; are we using the resources effectively? Postgrad Med J. 2006 Jul;82(969):465-7. doi: 10.1136/pgmj.2005.043547.

    PMID: 16822924RESULT

  • McVay MR, Kelley KR, Mathews DL, Jackson RJ, Kokoska ER, Smith SD. Postoperative follow-up: is a phone call enough? J Pediatr Surg. 2008 Jan;43(1):83-6. doi: 10.1016/j.jpedsurg.2007.09.025.

    PMID: 18206461RESULT

  • Scott AR, Rush AJ 3rd, Naik AD, Berger DH, Suliburk JW. Surgical follow-up costs disproportionately impact low-income patients. J Surg Res. 2015 Nov;199(1):32-8. doi: 10.1016/j.jss.2015.04.013. Epub 2015 Apr 10.

    PMID: 26013443RESULT

  • Tevis SE, Kennedy GD, Kent KC. Is There a Relationship Between Patient Satisfaction and Favorable Surgical Outcomes? Adv Surg. 2015;49(1):221-33. doi: 10.1016/j.yasu.2015.03.006.

    PMID: 26299501RESULT

  • Shirley ED, Sanders JO. Patient satisfaction: Implications and predictors of success. J Bone Joint Surg Am. 2013 May 15;95(10):e69. doi: 10.2106/JBJS.L.01048.

    PMID: 23677370RESULT

  • Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

    PMID: 19638912RESULT

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PMID: 15273542RESULT

  • Barrie A, Freeman AH, Lyon L, Garcia C, Conell C, Abbott LH, Littell RD, Powell CB. Classification of Postoperative Complications in Robotic-assisted Compared With Laparoscopic Hysterectomy for Endometrial Cancer. J Minim Invasive Gynecol. 2016 Nov-Dec;23(7):1181-1188. doi: 10.1016/j.jmig.2016.08.832. Epub 2016 Sep 9.

    PMID: 27621195RESULT

  • Hernandez Alava M, Wailoo A, Grimm S, Pudney S, Gomes M, Sadique Z, Meads D, O'Dwyer J, Barton G, Irvine L. EQ-5D-5L versus EQ-5D-3L: The Impact on Cost Effectiveness in the United Kingdom. Value Health. 2018 Jan;21(1):49-56. doi: 10.1016/j.jval.2017.09.004. Epub 2017 Oct 18.

    PMID: 29304940RESULT

  • Jiang N, Malkin BD. Use of Lean and CAHPS Surgical Care Survey to Improve Patients' Experiences with Surgical Care. Otolaryngol Head Neck Surg. 2016 Nov;155(5):743-747. doi: 10.1177/0194599816657051. Epub 2016 Jun 21.

    PMID: 27329420RESULT

  • McCaughey D, Stalley S, Williams E. Examining the effect of EVS spending on HCAHPS scores: a value optimization matrix for expense management. J Healthc Manag. 2013 Sep-Oct;58(5):320-34; discussion 334-5.

    PMID: 24195341RESULT

  • Schmocker RK, Cherney Stafford LM, Siy AB, Leverson GE, Winslow ER. Understanding the determinants of patient satisfaction with surgical care using the Consumer Assessment of Healthcare Providers and Systems surgical care survey (S-CAHPS). Surgery. 2015 Dec;158(6):1724-33. doi: 10.1016/j.surg.2015.06.018. Epub 2015 Jul 17.

    PMID: 26195107RESULT

  • Sundararajan V, Henderson T, Perry C, Muggivan A, Quan H, Ghali WA. New ICD-10 version of the Charlson comorbidity index predicted in-hospital mortality. J Clin Epidemiol. 2004 Dec;57(12):1288-94. doi: 10.1016/j.jclinepi.2004.03.012.

    PMID: 15617955RESULT

  • Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

    PMID: 3558716RESULT

  • Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.

    PMID: 12926578RESULT

  • Becerra Perez MM, Menear M, Brehaut JC, Legare F. Extent and Predictors of Decision Regret about Health Care Decisions: A Systematic Review. Med Decis Making. 2016 Aug;36(6):777-90. doi: 10.1177/0272989X16636113. Epub 2016 Mar 14.

    PMID: 26975351RESULT

  • 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.

    PMID: 19285921RESULT

  • AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol. 2011 Jan-Feb;18(1):1-3. doi: 10.1016/j.jmig.2010.10.001. Epub 2010 Nov 6. No abstract available.

    PMID: 21059487RESULT

  • EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

    PMID: 10109801RESULT

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Shan Biscette, MD

    University of Louisville School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Gynecology

Study Record Dates

First Submitted

May 2, 2018

First Posted

August 22, 2018

Study Start

August 8, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

April 26, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)