Surgical Success After Laparoscopic vs Abdominal Hysterectomy

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01793584
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 46.9
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metrorrhagia; Menorrhagia; Leiomyoma; Adenomyosis; Pelvic Pain; Endometriosis; Pelvic Inflammatory Disease	Procedure: Laparoscopic hysterectomy; Procedure: Abdominal hysterectomy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Dec 31, 2016
• Actual Study Completion Date: Dec 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Laparoscopic hysterectomy Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy	Procedure: Laparoscopic hysterectomy; LAVH, TLH
Active Comparator: Abdominal hysterectomy Total Abdominal Hysterectomy	Procedure: Abdominal hysterectomy; TAH

Outcome Measures

Primary Outcome Measures

1. Quality of life [1 year]

   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

Secondary Outcome Measures

1. Cost [1 year]

   Hospital charges and indirect costs of missed work/caregiving due to hysterectomy will be calculated

2. Complications [1 year]

   Intraoperative and postoperative complications including conversions, unintentional lacerations/injury to organs, hemorrhage, infection, wound complications, VTE, death, pain, neuropathy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parkland Hospital	Dallas	Texas	United States	75235

Sponsors and Collaborators

• University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Kimberly Kho, MD, MPH, University of Texas Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kinberly Kho, Associate Professor, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT01793584
• Other Study ID Numbers: STU 032012-067
• First Posted: Feb 15, 2013
• Last Update Posted: Oct 26, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Kinberly Kho, Associate Professor, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center: Comparative effectiveness; Surgical success
• Additional relevant MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection; Leiomyoma; Endometriosis; Menorrhagia; Adenomyosis; Metrorrhagia; Pelvic Pain

Study Results

No Results Posted as of Oct 26, 2017