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Surgical Success After Laparoscopic vs Abdominal Hysterectomy

NCT ID: NCT01793584

Last Updated: 2017-10-26

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-12-31

Brief Summary

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The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety, and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through a randomized surgical trial.

Detailed Description

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The overall hypothesis is that neither mode of hysterectomy will be consistently superior to the other with respect to each of the three domains of complications, cost, and patient-centered outcomes. The overall goal of the study is to determine which clinically relevant factors may impact the choice of LH compared to AH. The results of the study may be useful for clinicians, patients, hospital administrators and health policy makers.

Conditions

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Metrorrhagia Menorrhagia Leiomyoma Adenomyosis Pelvic Pain Endometriosis Pelvic Inflammatory Disease

Keywords

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Comparative effectiveness Surgical success

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Laparoscopic hysterectomy

Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy

Group Type ACTIVE_COMPARATOR

Laparoscopic hysterectomy

Intervention Type PROCEDURE

LAVH, TLH

Abdominal hysterectomy

Total Abdominal Hysterectomy

Group Type ACTIVE_COMPARATOR

Abdominal hysterectomy

Intervention Type PROCEDURE

TAH

Interventions

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Laparoscopic hysterectomy

LAVH, TLH

Intervention Type PROCEDURE

Abdominal hysterectomy

TAH

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women undergoing hysterectomy for benign indications within 8 weeks of enrollment
* Women \>18 years of age
* Non-emergent surgery
* Non-pregnant

Exclusion Criteria

* Candidate for vaginal hysterectomy
* Uterine size \>14 weeks by clinical exam OR \>300 mL by ultrasound measurement
* History of cancer of reproductive tract
* Requires concomitant pelvic organ prolapse (POP) surgery
* Requires surgery for urinary incontinence
* Has acute angle glaucoma
* Has severe cardiac/respiratory disease
* Desires supracervical hysterectomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kinberly Kho

Associate Professor, Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kimberly Kho, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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Parkland Hospital

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU 032012-067

Identifier Type: -

Identifier Source: org_study_id