A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02117492

Enrollment

Registered

2014-04-21

Start date

2014-05-31

Completion date

2017-05-31

Last updated

2017-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy

Keywords

hysterectomy, vaginal cuff

Brief 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.

Detailed 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.

Interventions

PROCEDURECuff Closure

Closure of the vaginal cuff following hysterectomy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Vaginal Length	up to 4-6 weeks post-operative	The primary endpoint measured in the study will be total vaginal length. This will be measured preoperatively, at 4-6 weeks postoperatively.

Secondary

Measure	Time frame	Description
Sexual Function	Pre-operative, 6 and 12 months post-operativey	Secondary outcomes will include sexual function measured with FSFI preoperatively and at 6 months and 12 months post operatively.

Other

Measure	Time frame	Description
Complication Rates	up to 12 months post-operativey	Overall complication rates will be monitored.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026