Surgical Success After Laparoscopic vs Abdominal Hysterectomy

The University of Texas System (UT)

Status: Completed

Conditions: Metrorrhagia; Pelvic Inflammatory Disease; Pelvic Pain; Endometriosis; Adenomyosis; Leiomyoma; Menorrhagia

Treatments: Procedure: Laparoscopic hysterectomy; Procedure: Abdominal hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01793584

STU 032012-067

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Laparoscopic hysterectomy

Active Comparator group

Description:

Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy

Treatment:

Procedure: Laparoscopic hysterectomy

Abdominal hysterectomy

Active Comparator group

Description:

Total Abdominal Hysterectomy

Treatment:

Procedure: Abdominal hysterectomy