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

Phase 4
18 Years
55 Years
Open (Enrolling)
Uterine Fibroids, Myomas

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Trial Information

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:



Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

November 2012

Completion Date:

September 2018

Related Keywords:

  • Uterine Fibroids
  • Myomas
  • Symptomatic Uterine Fibroids
  • Menorrhagia
  • Heavy Bleeding
  • Myomas
  • Leiomyoma
  • Myofibroma
  • Myoma