Endometriosis Clinical Trial
Official title:
Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success
Verified date | October 2017 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Parkland Hospital | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
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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