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Surgical Success After Laparoscopic vs Abdominal Hysterectomy

Primary Purpose

Metrorrhagia, Menorrhagia, Leiomyoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic hysterectomy
Abdominal hysterectomy
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Metrorrhagia focused on measuring Comparative effectiveness, Surgical success

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Parkland Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Laparoscopic hysterectomy

Abdominal hysterectomy

Arm Description

Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy

Total Abdominal Hysterectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 13, 2013
Last Updated
October 24, 2017
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01793584
Brief Title
Surgical Success After Laparoscopic vs Abdominal Hysterectomy
Official Title
Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metrorrhagia, Menorrhagia, Leiomyoma, Adenomyosis, Pelvic Pain, Endometriosis, Pelvic Inflammatory Disease
Keywords
Comparative effectiveness, Surgical success

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic hysterectomy
Arm Type
Active Comparator
Arm Description
Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy
Arm Title
Abdominal hysterectomy
Arm Type
Active Comparator
Arm Description
Total Abdominal Hysterectomy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic hysterectomy
Intervention Description
LAVH, TLH
Intervention Type
Procedure
Intervention Name(s)
Abdominal hysterectomy
Intervention Description
TAH
Primary Outcome Measure Information:
Title
Quality of life
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cost
Description
Hospital charges and indirect costs of missed work/caregiving due to hysterectomy will be calculated
Time Frame
1 year
Title
Complications
Description
Intraoperative and postoperative complications including conversions, unintentional lacerations/injury to organs, hemorrhage, infection, wound complications, VTE, death, pain, neuropathy
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Kho, MD, MPH
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkland Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

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Surgical Success After Laparoscopic vs Abdominal Hysterectomy

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