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The Effect of Vertical Versus Horizontal Vaginal Cuff Closure on Vaginal Length After Laparoscopic Hysterectomy

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: NCT02276261
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
Amanda Tower, Bridgeport Hospital

Brief Summary:
This study has been designed as a prospective randomized trial to be performed at Bridgeport Hospital. Patients planning to undergo a laparoscopic or robotically assisted total laparoscopic hysterectomy with or without removal of adnexal structures will be recruited by the Bridgeport Hospital Minimally Invasive Gynecologic Surgery fellows during their preoperative office visit at the Bridgeport Hospital Gynecologic Oncology office. If enrolled, they will be assigned a sequential study identification number. During their preoperative exam, a baseline POP-Q will be performed. Demographic information will be recorded from the electronic medical record.

Condition or disease Intervention/treatment Phase
Hysterectomy Procedure: Vaginal cuff closure - vertical Procedure: Vaginal cuff closure - horizontal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : November 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: Vertical
Vaginal cuff closure performed in a vertical manner.
Procedure: Vaginal cuff closure - vertical
Vaginal cuff is closed vertically.

Active Comparator: Horizontal
Vaginal cuff closure performed in a horizontal manner.
Procedure: Vaginal cuff closure - horizontal
Vaginal cuff is closed horizontally.




Primary Outcome Measures :
  1. Vaginal length [ Time Frame: 1-3 weeks postop ]
    Vaginal length will be measured in cm by standard POP-Q measurements


Secondary Outcome Measures :
  1. Vaginal length [ Time Frame: 3-4 months postop ]
    Vaginal length will be measured in cm by standard POP-Q measurements

  2. Cuff closure time [ Time Frame: intra-op ]
    Time will be recorded by the circulating nurse in seconds


Other Outcome Measures:
  1. Complications [ Time Frame: Up to 4 months post-op ]
    Including urinary retention, bladder injury, ureteral injury, cuff dehiscence, cuff bleeding requiring further procedures or cauterization



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Undergoing laparoscopic or robotic-assisted laparoscopic hysterectomy
  • Under the care of Dr. Dan-Arin Silasi or Dr. Masoud Azodi at Bridgeport Hospital
  • Planning to follow up at the Gynecologic Oncology office at Bridgeport Hospital
  • Age 18 or older
  • Able to give informed consent to participate in the research study

Exclusion Criteria:

  • Age less than 18
  • Unable to give informed consent
  • Patients undergoing radical hysterectomy
  • Patients receiving vaginal cuff radiation within the study period
  • Patients undergoing concomitant pelvic floor or vaginal suspension procedure

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): NCT02276261


Locations
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United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
Sponsors and Collaborators
Bridgeport Hospital
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Responsible Party: Amanda Tower, Fellow, Bridgeport Hospital
ClinicalTrials.gov Identifier: NCT02276261    
Other Study ID Numbers: 111401
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016