Surgical Success After Laparoscopic vs Abdominal Hysterectomy

Not Applicable

Completed

• Conditions: Adenomyosis; Pelvic Pain; Menorrhagia; Leiomyoma; Pelvic Inflammatory Disease; Metrorrhagia; Endometriosis
• Interventions: Procedure: Laparoscopic hysterectomy; Procedure: Abdominal hysterectomy

• Registration Number: NCT01793584
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-13
• Study First Posted: 2013-02-15
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Women undergoing hysterectomy for benign indications within 8 weeks of enrollment
• Women >18 years of age
• Non-emergent surgery
• Non-pregnant

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic hysterectomy	Laparoscopic hysterectomy	Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy
Abdominal hysterectomy	Abdominal hysterectomy	Total Abdominal Hysterectomy

Primary Outcome Measures

Name	Time	Method
Quality of life	1 year	1) Patient-centered outcomes composite; 1. Quality of life - measured using the Short Form 12 (SF-12v2),; 2. Sexual functioning - measured using the Sexual Activity Questionnaire (SAQ); 3. Body image - measured using the Body Image Scale (BIS); 4. Return to normal activity -measured using the Activities Assessment Scale (AAS); 5. Pain - measured using a 10 point likert scale; 6. Productivity - measured using a questionnaire about missed work

Secondary Outcome Measures

Name	Time	Method
Cost	1 year	Hospital charges and indirect costs of missed work/caregiving due to hysterectomy will be calculated
Complications	1 year	Intraoperative and postoperative complications including conversions, unintentional lacerations/injury to organs, hemorrhage, infection, wound complications, VTE, death, pain, neuropathy

Trial Locations

Locations (1)

Parkland Hospital; 🇺🇸 Dallas, Texas, United States