Surgical Success After Laparoscopic vs Abdominal Hysterectomy

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793584
• Other study ID #: STU 032012-067
• Status: Completed
• Phase: N/A
• First received: February 13, 2013
• Last updated: October 24, 2017
• Start date: February 2013
• Est. completion date: December 31, 2016

Study information

• Verified date: October 2017
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adenomyosis
• Endometriosis
• Leiomyoma
• Menorrhagia
• Metrorrhagia
• Pelvic Inflammatory Disease
• Pelvic Pain

Intervention

Procedure:
• Laparoscopic hysterectomy
LAVH, TLH
• Abdominal hysterectomy
TAH

Locations

Country	Name	City	State
United States	Parkland Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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