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

July 18, 2016 updated by: Amanda Tower, Bridgeport Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal length
Time Frame: 1-3 weeks postop
Vaginal length will be measured in cm by standard POP-Q measurements
1-3 weeks postop

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal length
Time Frame: 3-4 months postop
Vaginal length will be measured in cm by standard POP-Q measurements
3-4 months postop
Cuff closure time
Time Frame: intra-op
Time will be recorded by the circulating nurse in seconds
intra-op

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 4 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bridgeport Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (ESTIMATE)

October 28, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 111401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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