Goal Achievement and Patient Satisfaction in Benign Hysterectomy

Patient Satisfaction Clinical Trial

Official title:

Goal Achievement and Patient Satisfaction in Benign Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621710
• Other study ID #: 053161
• Status: Completed
• Phase: N/A
• First received: November 28, 2015
• Last updated: October 27, 2017
• Start date: December 2015
• Est. completion date: March 1, 2017

Study information

• Verified date: October 2017
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient undergoing hysterectomy for benign indication

• Age 18 or greater

• English speaking

• Access to communication via telephone

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Goal Achievement
• Hysterectomy
• Minimally Invasive Surgery
• Patient Satisfaction

Intervention

Other:
• Questionnaire 3 months post-operatively

Locations

Country	Name	City	State
United States	University Hospitals	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

ACOG Committee Opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009 Nov;114(5):1156-8. doi: 10.1097/AOG.0b013e3181c33c72. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2015;8:CD003677. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent of patient satisfaction	At three months post-operatively, patients will state how satisfied they are with their hysterectomy experience, from 0 to 100%.	3 months post-operatively