Laparoscopic Ultrasound Sparing Techniques Outcomes and Reinterventions - Full Text View

Purpose

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.

Condition	Intervention	Phase
Uterine Fibroids Myomas	Procedure: Global Fibroid Ablation Procedure: Myomectomy	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The LUSTOR (Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions)Trial

Resource links provided by NLM:

MedlinePlus related topics: Uterine Fibroids

U.S. FDA Resources

Further study details as provided by Halt Medical, Inc:

Primary Outcome Measures:

Compare the mean time of hospitalization following laparoscopic treatment of fibroids by myomectomy or GFA [ Time Frame: From admission to the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
Capture and compare hospitalization time expressed as the number of hours from induction of anesthesia to discharge from hospital.

Secondary Outcome Measures:

Compare and contrast post-treatment readmission and reintervention rate [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post treatment ] [ Designated as safety issue: No ]
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
Compare and Contrast peri and post procedural safety including procedural blood loss and complications [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment ] [ Designated as safety issue: Yes ]
Compare intraoperative blood loss and rate of procedural-related complications up to 60 months post treatment
Compare and contrast recovery rate [ Time Frame: Discharge from hospital up to an average of 5 weeks post treatment ] [ Designated as safety issue: No ]
Compare how many days it takes to return-to-work and to normal activities of daily living.
Compare and Contrast post-treatment changes in fibroid symptom severity. [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment ] [ Designated as safety issue: No ]
Compare Baseline fibroid related symptoms to 3, 6, 12, 24, 36, 48 and 60 months post treatment
Compare and contrast post-treatment patient satisfaction [ Time Frame: 3, 6, 12, 24, 36, 48, and 60 months post-treatment ] [ Designated as safety issue: No ]
Compare the overall subject treatment outcome and satisfaction evaluation
Compare and Contrast post-treatment changes in menstrual status. [ Time Frame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment ] [ Designated as safety issue: No ]
Compare Baseline menstrual impact to 3, 6, 12, 24, 36, 48 and 60 months post treatment.
Compare and Contrast post-treatment changes concerning health-related quality-of-life. [ Time Frame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment ] [ Designated as safety issue: No ]
Compare Baseline general health outcome to 3, 6, 12, 24, 36, 48 and 60 months post treatment.

Estimated Enrollment:	50
Study Start Date:	November 2012
Estimated Study Completion Date:	September 2018
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Global Fibroid Ablation Global Fibroid Ablation	Procedure: Global Fibroid Ablation Other Names: Halt Procedure Acessa Procedure
Laparoscopic Myomectomy Myomectomy via laparoscopy	Procedure: Myomectomy

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750008

Locations

Germany
Tubingen University Hospital	Recruiting
Tubingen, Germany, 72074
Contact: Emily Irslinger 49-7071-298-0791 Emily.Irslinger@med.uni-tuebingen.de
Principal Investigator: Sara Y Brucker, Prof. MD
Sub-Investigator: Bernhard Kraemer, MD
Sub-Investigator: Markus Hahn, MD

Sponsors and Collaborators

Halt Medical, Inc

More Information

Publications:

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.

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. Epub 2010 May 14.

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.

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.

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.

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.

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.

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. 2011 Jul 20. [Epub ahead of print]

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. Epub 2010 Nov 3.

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.

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.

Responsible Party:	Halt Medical, Inc
ClinicalTrials.gov Identifier:	NCT01750008 History of Changes
Other Study ID Numbers:	CP-00-0018
Study First Received:	December 11, 2012
Last Updated:	December 12, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Halt Medical, Inc:

Symptomatic Uterine Fibroids
Menorrhagia
Heavy Bleeding
Myomas

Additional relevant MeSH terms:

Leiomyoma
Myofibroma
Myoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 19, 2013

Laparoscopic Ultrasound Sparing Techniques Outcomes and Reinterventions (Lustor)