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Completed

NCT Number: NCT01793584

Surgical Success After Laparoscopic vs Abdominal Hysterectomy

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.

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Key information

Conditions

Metrorrhagia Adenomyosis Adnexal Diseases Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Infections Leiomyoma Menorrhagia Menstruation Disturbances Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Infection Pelvic Inflammatory Disease Pelvic Pain Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Hospital

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic hysterectomy

Procedure

LAVH, TLH

Abdominal hysterectomy

Procedure

TAH

Primary outcomes

  1. Quality of life

    Time frame: 1 year

    • 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 outcomes

  1. Cost

    Time frame: 1 year

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

  2. Complications

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 15, 2013
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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