NCT02621710

Brief Summary

This study evaluates patient goal achievement and satisfaction in benign hysterectomy. Patient's will state their goals prior to undergoing benign hysterectomy, and will receive a follow-up questionnaire 3 months post-operatively evaluating their perception of goal achievement and overall satisfaction. Goal achievement and satisfaction will be evaluated for association with surgical indication, surgical approach (minimally invasive vs abdominal surgery), and demographic information.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

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

November 28, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

November 28, 2015

Last Update Submit

October 27, 2017

Conditions

HysterectomyGoal AchievementPatient SatisfactionMinimally Invasive Surgery

Outcome Measures

Primary Outcomes (1)

  • Goal achievement score of 4 or 5

    Patients will state their goals prior to surgery, then at the three months post-operatively will rank if their goals were met on a 1-5 likert scale (1=strongly disagree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree). Goals are considered achieved with a likert score of 4 or 5.

    3 months post-operatively

Secondary Outcomes (1)

  • Percent of patient satisfaction

    3 months post-operatively

Study Arms (2)

Minimally invasive hysterectomy

Patients undergoing scheduled minimally invasive hysterectomy (vaginal, laparoscopic, robotic) for benign condition

Other: Questionnaire 3 months post-operatively

Abdominal hysterectomy

Patients undergoing scheduled abdominal hysterectomy for benign condition

Other: Questionnaire 3 months post-operatively

Interventions

Questionnaire 3 months post-operativelyOTHER
Abdominal hysterectomyMinimally invasive hysterectomy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing benign hysterectomy for benign indications in a scheduled manner

You may qualify if:

  • Patient undergoing hysterectomy for benign indication
  • Age 18 or greater
  • English speaking
  • Access to communication via telephone

You may not qualify if:

  • Patient undergoing hysterectomy for malignant or pre-malignant condition
  • Non-english speaking patient
  • Patient without telephone access
  • Patient undergoing emergent or unplanned hysterectomy
  • Vulnerable populations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Related Publications (11)

  • Pilzek AL, Raker CA, Sung VW. Are patients' personal goals achieved after pelvic reconstructive surgery? Int Urogynecol J. 2014 Mar;25(3):347-50. doi: 10.1007/s00192-013-2222-8. Epub 2013 Sep 18.

    PMID: 24045936BACKGROUND

  • Mamik MM, Rogers RG, Qualls CR, Komesu YM. Goal attainment after treatment in patients with symptomatic pelvic organ prolapse. Am J Obstet Gynecol. 2013 Nov;209(5):488.e1-5. doi: 10.1016/j.ajog.2013.06.011. Epub 2013 Jun 13.

    PMID: 23770473BACKGROUND

  • Hullfish KL, Bovbjerg VE, Gibson J, Steers WD. Patient-centered goals for pelvic floor dysfunction surgery: what is success, and is it achieved? Am J Obstet Gynecol. 2002 Jul;187(1):88-92. doi: 10.1067/mob.2002.124838.

    PMID: 12114893BACKGROUND

  • Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol. 2003 Dec;189(6):1551-7; discussion 1557-8. doi: 10.1016/s0002-9378(03)00932-3.

    PMID: 14710061BACKGROUND

  • Mahajan ST, Elkadry EA, Kenton KS, Shott S, Brubaker L. Patient-centered surgical outcomes: the impact of goal achievement and urge incontinence on patient satisfaction one year after surgery. Am J Obstet Gynecol. 2006 Mar;194(3):722-8. doi: 10.1016/j.ajog.2005.08.043.

    PMID: 16522404BACKGROUND

  • Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, van Voorst S, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD003677. doi: 10.1002/14651858.CD003677.pub4.

    PMID: 19588344BACKGROUND

  • ACOG Committee Opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009 Nov;114(5):1156-1158. doi: 10.1097/AOG.0b013e3181c33c72.

    PMID: 20168127BACKGROUND

  • Martino MA, Berger EA, McFetridge JT, Shubella J, Gosciniak G, Wejkszner T, Kainz GF, Patriarco J, Thomas MB, Boulay R. A comparison of quality outcome measures in patients having a hysterectomy for benign disease: robotic vs. non-robotic approaches. J Minim Invasive Gynecol. 2014 May-Jun;21(3):389-93. doi: 10.1016/j.jmig.2013.10.008. Epub 2013 Oct 26.

    PMID: 24513969BACKGROUND

  • Warren L, Ladapo JA, Borah BJ, Gunnarsson CL. Open abdominal versus laparoscopic and vaginal hysterectomy: analysis of a large United States payer measuring quality and cost of care. J Minim Invasive Gynecol. 2009 Sep-Oct;16(5):581-8. doi: 10.1016/j.jmig.2009.06.018.

    PMID: 19835801BACKGROUND

  • Wright KN, Jonsdottir GM, Jorgensen S, Shah N, Einarsson JI. Costs and outcomes of abdominal, vaginal, laparoscopic and robotic hysterectomies. JSLS. 2012 Oct-Dec;16(4):519-24. doi: 10.4293/108680812X13462882736736.

    PMID: 23484557BACKGROUND

  • Pitter MC, Simmonds C, Seshadri-Kreaden U, Hubert HB. The impact of different surgical modalities for hysterectomy on satisfaction and patient reported outcomes. Interact J Med Res. 2014 Jul 17;3(3):e11. doi: 10.2196/ijmr.3160.

    PMID: 25048103BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sangeeta Mahajan, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

November 28, 2015

First Posted

December 3, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

October 31, 2017

Record last verified: 2017-10

Locations

US(1)