Completed

Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success

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What is being tested

Laparoscopic hysterectomy

+ Abdominal hysterectomy

Procedure
Who is being recruted

Urogenital Diseases+25

+ Genital Diseases

+ Adnexal Diseases

From 18 to 80 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: October 26, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: October 26, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

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

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleHemorrhageInfectionsMenstruation DisturbancesNeoplasmsNeoplasms by Histologic TypeNeoplasms, Muscle TissueNeurologic ManifestationsPainPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsUterine DiseasesUterine HemorrhageNeoplasms, Connective and Soft TissuePelvic InfectionFemale Urogenital DiseasesPelvic Inflammatory DiseaseEndometriosisLeiomyomaMenorrhagiaMetrorrhagiaPelvic PainAdenomyosis

Criteria

4 inclusion criteria required to participate
Non-emergent surgery

Non-pregnant

Women > 18 years of age

Women undergoing hysterectomy for benign indications within 8 weeks of enrollment

8 exclusion criteria prevent from participating
Candidate for vaginal hysterectomy

Desires supracervical hysterectomy

Has acute angle glaucoma

Has severe cardiac/respiratory disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy

Group II

Active Comparator
Total Abdominal Hysterectomy

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Parkland Hospital

Dallas, United StatesOpen Parkland Hospital in Google Maps
CompletedOne Study Center