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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01793584
Other study ID # STU 032012-067
Secondary ID
Status Completed
Phase N/A
First received February 13, 2013
Last updated October 24, 2017
Start date February 2013
Est. completion date December 31, 2016

Study information

Verified date October 2017
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Procedure:
Laparoscopic hysterectomy
LAVH, TLH
Abdominal hysterectomy
TAH

Locations

Country Name City State
United States Parkland Hospital Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life 1) Patient-centered outcomes composite
Quality of life - measured using the Short Form 12 (SF-12v2),
Sexual functioning - measured using the Sexual Activity Questionnaire (SAQ)
Body image - measured using the Body Image Scale (BIS)
Return to normal activity -measured using the Activities Assessment Scale (AAS)
Pain - measured using a 10 point likert scale
Productivity - measured using a questionnaire about missed work
1 year
Secondary Cost Hospital charges and indirect costs of missed work/caregiving due to hysterectomy will be calculated 1 year
Secondary Complications Intraoperative and postoperative complications including conversions, unintentional lacerations/injury to organs, hemorrhage, infection, wound complications, VTE, death, pain, neuropathy 1 year
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