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A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02117492
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Timothy A Deimling, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Hysterectomy Procedure: Cuff Closure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure
Actual Study Start Date : May 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: Vertical Cuff
Vaginal cuff closure will be done vertically.
Procedure: Cuff Closure
Closure of the vaginal cuff following hysterectomy.

Experimental: Horizontal Cuff
Vaginal cuff closure will be done horizontally.
Procedure: Cuff Closure
Closure of the vaginal cuff following hysterectomy.




Primary Outcome Measures :
  1. Vaginal Length [ Time Frame: 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 Outcome Measures :
  1. Sexual Function [ Time Frame: 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 Outcome Measures:
  1. Complication Rates [ Time Frame: up to 12 months post-operativey ]
    Overall complication rates will be monitored.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117492


Locations
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United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Timothy A Deimling, MD, MS Milton S. Hershey Medical Center
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Responsible Party: Timothy A Deimling, Minimally Invastive GYN Surgery, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02117492    
Other Study ID Numbers: 00000143
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Timothy A Deimling, Milton S. Hershey Medical Center:
hysterectomy
vaginal cuff