Surgical Success After Laparoscopic vs Abdominal Hysterectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metrorrhagia, Menorrhagia, Leiomyoma, Adenomyosis, Pelvic Pain, Endometriosis, Pelvic Inflammatory Disease

Intervention / Treatment
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* Procedure: Laparoscopic hysterectomy
* Procedure: Abdominal hysterectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic hysterectomy<br>Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy | Procedure: Laparoscopic hysterectomy<br>* LAVH, TLH<br>|
| Active Comparator: Abdominal hysterectomy<br>Total Abdominal Hysterectomy | Procedure: Abdominal hysterectomy<br>* TAH<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comparative effectiveness, Surgical success