Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions

Uterine Fibroids Clinical Trial

— LUSTOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750008
• Other study ID #: CP-00-0018
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: June 2018

Study information

• Verified date: November 2018
• Source: Acessa Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 2018
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leiomyoma
• Myomas
• Uterine Fibroids

Intervention

Procedure:
• Global Fibroid Ablation

• Myomectomy

Locations

Country	Name	City	State
Germany	Tubingen University Hospital	Tubingen

Sponsors (1)

Lead Sponsor	Collaborator
Acessa Health, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (22)

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. — View Citation

Brucker SY, Hahn M, Kraemer D, Taran FA, Isaacson KB, Krämer 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 Fe — View 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. — View 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):1075-82. doi: 10.1097/AOG.0b013e31828b7962. — View 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. — View 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. — View Citation

Hahn M, Brucker S, Kraemer D, Wallwiener M, Taran FA, Wallwiener CW, Krämer B. Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy: Long-Term Follow-up From a Randomized Trial. Geburtshilfe Frauenheilkd. 2015 May;75(5):442-4 — View 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. — View 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. — View Citation

Krämer 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. 20 — View 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.

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. — View 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. Epub 2007 Oct 18. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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

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. Review. — View 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: — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the mean time of hospitalization following laparoscopic treatment of fibroids by myomectomy or GFA	Capture and compare hospitalization time expressed as the number of hours from induction of anesthesia to discharge from hospital.	From admission to the duration of hospital stay, an expected average of 3 days
Secondary	Compare and contrast post-treatment readmission and reintervention rate	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	Baseline and 3, 6, 12, 24, 36, 48, and 60 months post treatment
Secondary	Compare and Contrast peri and post procedural safety including procedural blood loss and complications	Compare intraoperative blood loss and rate of procedural-related complications up to 60 months post treatment	Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Secondary	Compare and contrast recovery rate	Compare how many days it takes to return-to-work and to normal activities of daily living.	Discharge from hospital up to an average of 5 weeks post treatment
Secondary	Compare and Contrast post-treatment changes in fibroid symptom severity.	Compare Baseline fibroid related symptoms to 3, 6, 12, 24, 36, 48 and 60 months post treatment	Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Secondary	Compare and contrast post-treatment patient satisfaction	Compare the overall subject treatment outcome and satisfaction evaluation	3, 6, 12, 24, 36, 48, and 60 months post-treatment
Secondary	Compare and Contrast post-treatment changes in menstrual status.	Compare Baseline menstrual impact to 3, 6, 12, 24, 36, 48 and 60 months post treatment.	Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment
Secondary	Compare and Contrast post-treatment changes concerning health-related quality-of-life.	Compare Baseline general health outcome to 3, 6, 12, 24, 36, 48 and 60 months post treatment.	Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment