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.