Skip to main content
OpenTrials
Completed

NCT Number: NCT01750008

Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions

The purpose of this study is to compare the outcomes of two uterine-conserving treatment alternatives for symptomatic uterine fibroids: laparoscopic myomectomy (LM) and global fibroid ablation (GFA) using the Halt System. Laparoscopic ultrasound (LUS) is a standard step prior to the GFA procedure but has not been a standard step prior to LM. Incorporating laparoscopic ultrasound as a first step prior to both treatments allows the surgeon to have equal access to valuable imaging information and to plan treatment accordingly. By randomizing the subject immediately after laparoscopic ultrasound, selection bias toward one treatment or the other following the LUS is eliminated.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uterine Fibroids Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Leiomyoma Menorrhagia Menstruation Disturbances Myoma Myomas Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tubingen University Hospital

Tübingen, 72074, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Are ≥ 18 years old and menstruating
  • Have symptomatic uterine fibroids
  • Have a uterine size ≤16 gestational weeks as determined by pelvic exam
  • Have fibroids that are less than 10 cm in any diameter
  • Desire uterine conservation
  • Have had a normal Papanicolaou test (PAP smear) (i.e. PAP I or PAP II) at the latest pre-study examination and no longer than 36 months before study entry.
  • Are willing and able to comply with all study tests, procedures, and assessment tools
  • Are capable of providing informed consent.

Exclusion criteria

  • Have contraindications for laparoscopic surgery and/or general anesthesia.
  • Are expected to be high risk for, or are known to have, significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus)
  • Patients requiring major elective concomitant procedures (e.g., hernia repair, hysteroscopic resection, endometrial ablation, uterine artery ligation, etc.) that could confound the results of the study
  • Are pregnant or lactating
  • Have taken any depot Gonadotropin-releasing hormone (GnRh agonist within three months prior to the screening procedures
  • Have an implanted intrauterine or fallopian tube device for contraception that cannot or will not be removed at least ten days prior to treatment
  • Have chronic pelvic pain not due to uterine fibroids
  • Have known or suspected endometriosis or adenomyosis
  • Have active or history of pelvic inflammatory disease
  • Have a history of, or evidence of, gynecologic malignancy or pre-malignancy within the past five years
  • Have had pelvic radiation
  • Have a non-uterine pelvic mass over 3 cm
  • Have a cervical myoma
  • Have one or more completely intracavitary submucous fibroids (Type 0) or only Type 0/1 submucous fibroids that are better treated via hysteroscopic methods
  • In the medical judgment of the investigator should not participate in the study
  • Are not willing to be randomized to treatment.

Treatment and study plan

Global Fibroid Ablation

Procedure

Other names: Halt Procedure, Acessa Procedure

Myomectomy

Procedure

Primary outcomes

  1. Compare the mean time of hospitalization following laparoscopic treatment of fibroids by myomectomy or GFA

    Time frame: From admission to the duration of hospital stay, an expected average of 3 days

    Capture and compare hospitalization time expressed as the number of hours from induction of anesthesia to discharge from hospital.

Secondary outcomes

  1. Compare and contrast post-treatment readmission and reintervention rate

    Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post treatment

    Compare incidence of post discharge readmission within 1 month of procedure and rate of reintervention for fibroid-related symptoms up to 60 months post procedure

  2. Compare and Contrast peri and post procedural safety including procedural blood loss and complications

    Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment

    Compare intraoperative blood loss and rate of procedural-related complications up to 60 months post treatment

  3. Compare and contrast recovery rate

    Time frame: Discharge from hospital up to an average of 5 weeks post treatment

    Compare how many days it takes to return-to-work and to normal activities of daily living.

  4. Compare and Contrast post-treatment changes in fibroid symptom severity.

    Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment

    Compare Baseline fibroid related symptoms to 3, 6, 12, 24, 36, 48 and 60 months post treatment

  5. Compare and contrast post-treatment patient satisfaction

    Time frame: 3, 6, 12, 24, 36, 48, and 60 months post-treatment

    Compare the overall subject treatment outcome and satisfaction evaluation

  6. Compare and Contrast post-treatment changes in menstrual status.

    Time frame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment

    Compare Baseline menstrual impact to 3, 6, 12, 24, 36, 48 and 60 months post treatment.

  7. Compare and Contrast post-treatment changes concerning health-related quality-of-life.

    Time frame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment

    Compare Baseline general health outcome to 3, 6, 12, 24, 36, 48 and 60 months post treatment.

Sponsors and collaborators

Lead sponsor

Acessa Health, Inc.

Industry

Registry information

Official study title

The LUSTOR (Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions)Trial

Acronym: LUSTOR

Important dates

Study start
2012
Primary completion
2013
Study completion
2018
First posted
Dec 17, 2012
Registry last updated
Nov 20, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.