A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure

Hysterectomy Clinical Trial

Official title:

A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02117492
• Other study ID #: 00000143
• Status: Completed
• Phase: N/A
• First received: April 16, 2014
• Last updated: September 19, 2017
• Start date: May 2014
• Est. completion date: May 2017

Study information

• Verified date: September 2017
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the possible impacts of two techniques of vaginal cuff closure during robotic hysterectomy. We aim to compare vertical vs horizontal vaginal cuff closure and the impact that these techniques have on vaginal length, sexual function, and overall complication rates.

Description:

A Validated questionnaire the Female Sexual Function Index (FSFI) and total vaginal lengths will be used to evaluate patients pre-operatively, at 4-6 weeks post-operatively, and 6 months post operatively. The FSFI will also be sent to the patient 12 months post operatively. These data will be used to assess sexual function and total vaginal length in patients undergoing minimally invasive hysterectomy. The study endpoint will occur after the 12 month follow-up questionnaire. Additionally, all complications following surgery will be tracked over the study period for comparison.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female premenopausal patients undergoing robot assisted total laparoscopic hysterectomy

Exclusion Criteria:

1. Adults unable to consent

2. Children under the age of 18

3. Pregnant women

4. Prisoners

5. Post-menopausal women

6. Women with the known preoperative need for bowel or genitourinary surgery at the time of hysterectomy

7. Patients unable to consent to the procedure in the English language

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Procedure:
• Cuff Closure
Closure of the vaginal cuff following hysterectomy.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complication Rates	Overall complication rates will be monitored.	up to 12 months post-operativey
Primary	Vaginal Length	The primary endpoint measured in the study will be total vaginal length. This will be measured preoperatively, at 4-6 weeks postoperatively.	up to 4-6 weeks post-operative
Secondary	Sexual Function	Secondary outcomes will include sexual function measured with FSFI preoperatively and at 6 months and 12 months post operatively.	Pre-operative, 6 and 12 months post-operativey