Clinical trial NCT01750008: Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions
Official title: The LUSTOR (Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions)Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroids
Myomas
Keywords: Symptomatic Uterine Fibroids
Menorrhagia
Heavy Bleeding
Myomas
Radiofrequency Ablation
RFA
Leiomyoma
Fibroids
Lead sponsor: Acessa Health, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-17
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study compares two laparoscopic interventions for the treatment of symptomatic uterine fibroids.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Compare the mean time of hospitalization following laparoscopic treatment of fibroids by myomectomy or GFA
timeFrame: From admission to the duration of hospital stay, an expected average of 3 days
Secondary outcomes:
measure: Compare and contrast post-treatment readmission and reintervention rate
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post treatment
measure: Compare and Contrast peri and post procedural safety including procedural blood loss and complications
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment
measure: Compare and contrast recovery rate
timeFrame: Discharge from hospital up to an average of 5 weeks post treatment
measure: Compare and Contrast post-treatment changes in fibroid symptom severity.
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment
measure: Compare and contrast post-treatment patient satisfaction
timeFrame: 3, 6, 12, 24, 36, 48, and 60 months post-treatment
measure: Compare and Contrast post-treatment changes in menstrual status.
timeFrame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment
measure: Compare and Contrast post-treatment changes concerning health-related quality-of-life.
timeFrame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment
Other outcomes:
Locations:
city: Tubingen
country: Germany
facility: Tubingen University Hospital
Study officials:
affiliation: University of Tubingen
name: Sara Brucker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300. doi: 10.1016/s0029-7844(01)01702-1.
citation: Twijnstra AR, Kolkman W, Trimbos-Kemper GC, Jansen FW. Implementation of advanced laparoscopic surgery in gynecology: national overview of trends. J Minim Invasive Gynecol. 2010 Jul-Aug;17(4):487-92. doi: 10.1016/j.jmig.2010.03.010. Epub 2010 May 14.
citation: Viswanathan M, Hartmann K, McKoy N, Stuart G, Rankins N, Thieda P, Lux LJ, Lohr KN. Management of uterine fibroids: an update of the evidence. Evid Rep Technol Assess (Full Rep). 2007 Jul;(154):1-122.
citation: Holzer A, Jirecek ST, Illievich UM, Huber J, Wenzl RJ. Laparoscopic versus open myomectomy: a double-blind study to evaluate postoperative pain. Anesth Analg. 2006 May;102(5):1480-4. doi: 10.1213/01.ane.0000204321.85599.0d.
citation: Parker WH, Iacampo K, Long T. Uterine rupture after laparoscopic removal of a pedunculated myoma. J Minim Invasive Gynecol. 2007 May-Jun;14(3):362-4. doi: 10.1016/j.jmig.2006.10.024.
citation: Banas T, Klimek M, Fugiel A, Skotniczny K. Spontaneous uterine rupture at 35 weeks' gestation, 3 years after laparoscopic myomectomy, without signs of fetal distress. J Obstet Gynaecol Res. 2005 Dec;31(6):527-30. doi: 10.1111/j.1447-0756.2005.00331.x.
citation: Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):73-85. doi: 10.1007/s00270-007-9195-2. Epub 2007 Oct 18.
citation: Manyonda IT, Bratby M, Horst JS, Banu N, Gorti M, Belli AM. Uterine artery embolization versus myomectomy: impact on quality of life--results of the FUME (Fibroids of the Uterus: Myomectomy versus Embolization) Trial. Cardiovasc Intervent Radiol. 2012 Jun;35(3):530-6. doi: 10.1007/s00270-011-0228-5. Epub 2011 Jul 20.
citation: Munro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on Menstrual Disorders. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011 Apr;113(1):3-13. doi: 10.1016/j.ijgo.2010.11.011. Epub 2011 Feb 22.
citation: Bushnell DM, Martin ML, Moore KA, Richter HE, Rubin A, Patrick DL. Menorrhagia Impact Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life. Curr Med Res Opin. 2010 Dec;26(12):2745-55. doi: 10.1185/03007995.2010.532200. Epub 2010 Nov 3.
citation: Hartung J, Knapp G. On tests of the overall treatment effect in meta-analysis with normally distributed responses. Stat Med. 2001 Jun 30;20(12):1771-82. doi: 10.1002/sim.791.
citation: Levine DJ, Harris M, Berman JM, Macer J, Abbott K, Lee BB. Leiomyoma assessment by intra-abdominal ultrasound compared to preoperative ultrasound and preoperative magnetic imaging. J Minim Invasive Gynecol. 2011;18(suppl):S1.
citation: Moss JG, Cooper KG, Khaund A, Murray LS, Murray GD, Wu O, Craig LE, Lumsden MA. Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results. BJOG. 2011 Jul;118(8):936-44. doi: 10.1111/j.1471-0528.2011.02952.x. Epub 2011 Apr 12.
citation: U.S. Valuation of the EuroQoL EQ-5D Health States. December 2005. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gove/rice/EQ5Dproj.htm
citation: Chudnoff SG, Berman JM, Levine DJ, Harris M, Guido RS, Banks E. Outpatient procedure for the treatment and relief of symptomatic uterine myomas. Obstet Gynecol. 2013 May;121(5):1075-1082. doi: 10.1097/AOG.0b013e31828b7962.
citation: Robles R, Aguirre VA, Argueta AI, Guerrero MR. Laparoscopic radiofrequency volumetric thermal ablation of uterine myomas with 12 months of follow-up. Int J Gynaecol Obstet. 2013 Jan;120(1):65-9. doi: 10.1016/j.ijgo.2012.07.023. Epub 2012 Oct 14.
citation: Garza Leal JG, Hernandez Leon I, Castillo Saenz L, Lee BB. Laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic uterine leiomyomas: feasibility study using the Halt 2000 Ablation System. J Minim Invasive Gynecol. 2011 May-Jun;18(3):364-71. doi: 10.1016/j.jmig.2011.02.006.
citation: Guido RS, Macer JA, Abbott K, Falls JL, Tilley IB, Chudnoff SG. Radiofrequency volumetric thermal ablation of fibroids: a prospective, clinical analysis of two years' outcome from the Halt trial. Health Qual Life Outcomes. 2013 Aug 13;11:139. doi: 10.1186/1477-7525-11-139.
citation: Brucker SY, Hahn M, Kraemer D, Taran FA, Isaacson KB, Kramer B. Laparoscopic radiofrequency volumetric thermal ablation of fibroids versus laparoscopic myomectomy. Int J Gynaecol Obstet. 2014 Jun;125(3):261-5. doi: 10.1016/j.ijgo.2013.11.012. Epub 2014 Feb 28.
citation: Hahn M, Brucker S, Kraemer D, Wallwiener M, Taran FA, Wallwiener CW, Kramer B. Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy: Long-Term Follow-up From a Randomized Trial. Geburtshilfe Frauenheilkd. 2015 May;75(5):442-449. doi: 10.1055/s-0035-1545931.
citation: Kramer B, Hahn M, Taran FA, Kraemer D, Isaacson KB, Brucker SY. Interim analysis of a randomized controlled trial comparing laparoscopic radiofrequency volumetric thermal ablation of uterine fibroids with laparoscopic myomectomy. Int J Gynaecol Obstet. 2016 May;133(2):206-11. doi: 10.1016/j.ijgo.2015.10.008. Epub 2015 Dec 31.
citation: Walter CB, Hartkopf AD, Schoeller D, Kraemer B, Neis F, Taran FA, Isaacson KB, Brucker SY, Hahn M. Ultrasound guided core needle biopsy prior to thermo ablative treatment of uterine tumors: first results. Arch Gynecol Obstet. 2018 Feb;297(2):387-392. doi: 10.1007/s00404-017-4590-7. Epub 2017 Nov 24.
citation: Berman JM, Guido RS, Garza Leal JG, Pemueller RR, Whaley FS, Chudnoff SG; Halt Study Group. Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas. J Minim Invasive Gynecol. 2014 Sep-Oct;21(5):767-74. doi: 10.1016/j.jmig.2014.02.015. Epub 2014 Mar 5.