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

NCT ID: NCT02276261

Last Updated: 2016-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Vertical

Vaginal cuff closure performed in a vertical manner.

Group Type EXPERIMENTAL

Vaginal cuff closure - vertical

Intervention Type PROCEDURE

Vaginal cuff is closed vertically.

Horizontal

Vaginal cuff closure performed in a horizontal manner.

Group Type ACTIVE_COMPARATOR

Vaginal cuff closure - horizontal

Intervention Type PROCEDURE

Vaginal cuff is closed horizontally.

Interventions

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Vaginal cuff closure - vertical

Vaginal cuff is closed vertically.

Intervention Type PROCEDURE

Vaginal cuff closure - horizontal

Vaginal cuff is closed horizontally.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bridgeport Hospital

OTHER

Sponsor Role lead

Responsible Party

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Amanda Tower

Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bridgeport Hospital

Bridgeport, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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111401

Identifier Type: -

Identifier Source: org_study_id

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