NCT01793584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

3.9 years

First QC Date

February 13, 2013

Last Update Submit

October 24, 2017

Conditions

MetrorrhagiaMenorrhagiaLeiomyomaAdenomyosisPelvic PainEndometriosisPelvic Inflammatory Disease

Keywords

Comparative effectivenessSurgical success

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    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

    1 year

Secondary Outcomes (2)

  • Cost

    1 year

  • Complications

    1 year

Study Arms (2)

Laparoscopic hysterectomy

ACTIVE COMPARATOR

Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy

Procedure: Laparoscopic hysterectomy

Abdominal hysterectomy

ACTIVE COMPARATOR

Total Abdominal Hysterectomy

Procedure: Abdominal hysterectomy

Interventions

Laparoscopic hysterectomyPROCEDURE

LAVH, TLH

Laparoscopic hysterectomy
Abdominal hysterectomyPROCEDURE

TAH

Abdominal hysterectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

MetrorrhagiaMenorrhagiaLeiomyomaAdenomyosisPelvic PainEndometriosisPelvic Inflammatory Disease

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation DisturbancesNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsPainNeurologic ManifestationsSigns and SymptomsPelvic InfectionInfectionsAdnexal Diseases

Study Officials

  • Kimberly Kho, MD, MPH

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 15, 2013

Study Start

February 1, 2013

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

US(1)