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


Phase 4
18 Years
80 Years
Open (Enrolling)
Female
Metrorrhagia, Menorrhagia, Leiomyoma, Adenomyosis, Pelvic Pain, Endometriosis, Pelvic Inflammatory Disease

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Quality of life

Outcome Description:

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

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Kimberly Kho, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Southwestern Medical Center

Authority:

United States: Institutional Review Board

Study ID:

STU 032012-067

NCT ID:

NCT01793584

Start Date:

February 2013

Completion Date:

June 2015

Related Keywords:

  • Metrorrhagia
  • Menorrhagia
  • Leiomyoma
  • Adenomyosis
  • Pelvic Pain
  • Endometriosis
  • Pelvic Inflammatory Disease
  • Comparative effectiveness
  • Surgical success
  • Endometriosis
  • Leiomyoma
  • Myofibroma
  • Menorrhagia
  • Metrorrhagia
  • Pelvic Pain
  • Pelvic Inflammatory Disease
  • Pelvic Infection

Name

Location
Parkland Hospital Dallas, Texas  75390