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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Global Fibroid Ablation | Other | Global Fibroid Ablation |
|
| Laparoscopic Myomectomy | Other | Myomectomy via laparoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Global Fibroid Ablation | Procedure |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Compare and Contrast peri and post procedural safety including procedural blood loss and complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Brucker, MD | University of Tubingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tubingen University Hospital | Tübingen | 72074 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11814511 | Background | 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. | |
| 20471917 | Background | 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. |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D009214 | Myoma |
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D063186 | Uterine Myomectomy |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Study compares two laparoscopic interventions for the treatment of symptomatic uterine fibroids.
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| Myomectomy |
| Procedure |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 18288885 | Background | 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. |
| 16632830 | Background | 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. |
| 17478371 | Background | 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. |
| 16343253 | Background | 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. |
| 17943348 | Background | 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. |
| 21773858 | Background | 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. |
| 21345435 | Background | 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. |
| 21043553 | Background | 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. |
| 11406840 | Background | 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. |
| Background | 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. |
| 21481151 | Background | 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. |
| Background | 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 |
| 23635746 | Background | 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. |
| 23073229 | Background | 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. |
| 21545960 | Background | 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. |
| 23941588 | Background | 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. |
| 24698202 | Result | 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. |
| 26097247 | Result | 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. |
| 26892690 | Result | 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. |
| 29177589 | Result | 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. |
| 24613404 | Derived | 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. |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |